Illustrates Domains
BDS
Illustrates Variables
TPTREF
DVID
TRTP
TRTA
APHASE
APERIOD
ARM
ACTARM
COHORT
AVAL
PCSTRESC
Illustrates Data Structures
BDS
Content
Example developed for the Basic Data Structure for ADaM PopPK Implementation Guide v1.0.
This example shows a combined dataset from multiple studies, with the addition of an IV dose. This combined example includes both a tablet and IV.
adppk.xpt
| PROJID | PROJIDN | STUDYID | STUDYIDN | PART | EXTEN | USUBJID | USUBJIDN | SUBJID | SITEID | SITEIDN | AVISIT | AVISITN | VISIT | VISITNUM | AFRLT | TPTREF | APRLT | NFRLT | NPRLT | ATPT | ATPTN | ADT | ATM | ADY | AENDT | AENTM | OCC | DVID | DVIDN | CMT | DV | DVL | EVID | MDV | AULOQ | ALLOQ | BLQFN | BLQFL | ALQFN | ALQFL | DOSEA | DOSEP | AMT | II | ADDL | SS | RATE | DUR | FORM | FORMN | ROUTE | ROUTEN | TRTP | TRTPN | TRTA | TRTAN | APHASE | APHASEN | APERIOD | APERIODC | ARM | ARMN | ACTARM | ACTARMN | COHORT | COHORTN | WT | WTBL | HTBL | BMIBL | BSABL | AGE | SEX | SEXN | RACE | RACEN | ETHNIC | ETHNICN | REGION | REGIONN | COUNTRY | COUNTRYN | CREATBL | UCREATBL | CRCLBL | EGFRBL | TBILBL | ASTBL | ALTBL | AVAL | PCSTRESC | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-05-21 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | BLQ | ||
| 2 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-05-21 | 07:54 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 87.03 | 4.466299 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 87.03 | 87.03 | ||
| 3 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0 | DAY 1 DOSE | 0 | 0 | 0 | DOSE | 0 | 2020-05-21 | 08:00 | 1 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | |||
| 4 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-05-21 | 08:15 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 1.97 | 0.678629 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.97 | 1.97 | ||
| 5 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-05-21 | 08:15 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 70.02 | 4.248754 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 70.02 | 70.02 | ||
| 6 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-05-21 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 2.98 | 1.090316 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.98 | 2.98 | ||
| 7 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-05-21 | 08:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 73.69 | 4.299825 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 73.69 | 73.69 | ||
| 8 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-05-21 | 08:45 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 6.44 | 1.861801 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 6.44 | 6.44 | ||
| 9 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-05-21 | 08:45 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 76.98 | 4.343546 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 76.98 | 76.98 | ||
| 10 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 DOSE | 1 | 1 | 1 | 1H | 1 | 2020-05-21 | 09:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.80 | 2.282835 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.80 | 9.8 | ||
| 11 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 DOSE | 1 | 1 | 1 | 1H | 1 | 2020-05-21 | 09:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 65.98 | 4.189386 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 65.98 | 65.98 | ||
| 12 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-05-21 | 09:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.41 | 2.518406 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.41 | 12.41 | ||
| 13 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-05-21 | 09:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 71.67 | 4.272099 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 71.67 | 71.67 | ||
| 14 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 DOSE | 2 | 2 | 2 | 2H | 2 | 2020-05-21 | 10:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.21 | 2.219783 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.21 | 9.21 | ||
| 15 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 DOSE | 2 | 2 | 2 | 2H | 2 | 2020-05-21 | 10:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 81.56 | 4.401337 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 81.56 | 81.56 | ||
| 16 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2020-05-21 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 17.40 | 2.856257 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.40 | 17.4 | ||
| 17 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2020-05-21 | 11:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 71.20 | 4.265473 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 71.20 | 71.2 | ||
| 18 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 DOSE | 4 | 4 | 4 | 4H | 4 | 2020-05-21 | 12:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 14.24 | 2.655828 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 14.24 | 14.24 | ||
| 19 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 DOSE | 4 | 4 | 4 | 4H | 4 | 2020-05-21 | 12:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 60.43 | 4.101539 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 60.43 | 60.43 | ||
| 20 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2020-05-21 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 16.98 | 2.831832 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 16.98 | 16.98 | ||
| 21 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2020-05-21 | 14:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 84.68 | 4.438878 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 84.68 | 84.68 | ||
| 22 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 DOSE | 8 | 8 | 8 | 8H | 8 | 2020-05-21 | 16:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.99 | 2.564352 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.99 | 12.99 | ||
| 23 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 DOSE | 8 | 8 | 8 | 8H | 8 | 2020-05-21 | 16:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 86.48 | 4.459932 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 86.48 | 86.48 | ||
| 24 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2020-05-21 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 19.51 | 2.970776 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 19.51 | 19.51 | ||
| 25 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2020-05-21 | 20:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 75.16 | 4.319583 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 75.16 | 75.16 | ||
| 26 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 2 | 1 | DAY 2 | 2 | 24 | DAY 1 DOSE | 24 | 24 | 24 | 1D | 24 | 2020-05-21 | 08:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 12.01 | 2.485983 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.01 | 12.01 | ||
| 27 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 2 | 1 | DAY 2 | 2 | 24 | DAY 1 DOSE | 24 | 24 | 24 | 1D | 24 | 2020-05-21 | 08:00 | 2 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 89.63 | 4.495745 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 89.63 | 89.63 | ||
| 28 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 3 | 1 | DAY 3 | 3 | 48 | DAY 1 DOSE | 48 | 48 | 48 | 2D | 48 | 2020-05-21 | 08:00 | 3 | 1 | DRUG (ng/mL) | 1 | 2 | 10.18 | 2.320054 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 10.18 | 10.18 | ||
| 29 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 3 | 1 | DAY 3 | 3 | 48 | DAY 1 DOSE | 48 | 48 | 48 | 2D | 48 | 2020-05-21 | 08:00 | 3 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 80.25 | 4.385157 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 80.25 | 80.25 | ||
| 30 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 4 | 1 | DAY 4 | 4 | 72 | DAY 1 DOSE | 72 | 72 | 72 | 3D | 72 | 2020-05-21 | 08:00 | 4 | 1 | DRUG (ng/mL) | 1 | 2 | 8.90 | 2.185528 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.90 | 8.9 | ||
| 31 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 4 | 1 | DAY 4 | 4 | 72 | DAY 1 DOSE | 72 | 72 | 72 | 3D | 72 | 2020-05-21 | 08:00 | 4 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 78.60 | 4.364427 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 78.60 | 78.6 | ||
| 32 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 5 | 1 | DAY 5 | 5 | 96 | DAY 1 DOSE | 96 | 96 | 96 | 4D | 96 | 2020-05-21 | 08:00 | 5 | 1 | DRUG (ng/mL) | 1 | 2 | 8.31 | 2.117239 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.31 | 8.31 | ||
| 33 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 5 | 1 | DAY 5 | 5 | 96 | DAY 1 DOSE | 96 | 96 | 96 | 4D | 96 | 2020-05-21 | 08:00 | 5 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 70.41 | 4.254365 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 70.41 | 70.41 | ||
| 34 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 6 | 1 | DAY 6 | 6 | 120 | DAY 1 DOSE | 120 | 120 | 120 | 5D | 120 | 2020-05-21 | 08:00 | 6 | 1 | DRUG (ng/mL) | 1 | 2 | 6.98 | 1.943693 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 6.98 | 6.98 | ||
| 35 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 6 | 1 | DAY 6 | 6 | 120 | DAY 1 DOSE | 120 | 120 | 120 | 5D | 120 | 2020-05-21 | 08:00 | 6 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 75.25 | 4.320808 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 75.25 | 75.25 | ||
| 36 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 7 | 1 | DAY 7 | 7 | 144 | DAY 1 DOSE | 144 | 144 | 144 | 6D | 144 | 2020-05-21 | 08:00 | 7 | 1 | DRUG (ng/mL) | 1 | 2 | 2.25 | 0.810999 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.25 | 2.25 | ||
| 37 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 7 | 1 | DAY 7 | 7 | 144 | DAY 1 DOSE | 144 | 144 | 144 | 6D | 144 | 2020-05-21 | 08:00 | 7 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 77.43 | 4.349329 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 77.43 | 77.43 | ||
| 38 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 8 | 1 | DAY 8 | 8 | 168 | DAY 1 DOSE | 168 | 168 | 168 | 7D | 168 | 2020-05-21 | 08:00 | 8 | 1 | DRUG (ng/mL) | 1 | 2 | 2.50 | 0.91774 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.50 | 2.5 | ||
| 39 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 8 | 1 | DAY 8 | 8 | 168 | DAY 1 DOSE | 168 | 168 | 168 | 7D | 168 | 2020-05-21 | 08:00 | 8 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 85.56 | 4.449228 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 85.56 | 85.56 | ||
| 40 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 9 | 1 | DAY 9 | 9 | 192 | DAY 1 DOSE | 192 | 192 | 192 | 8D | 192 | 2020-05-21 | 08:00 | 9 | 1 | DRUG (ng/mL) | 1 | 2 | 2.94 | 1.078083 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.94 | 2.94 | ||
| 41 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 9 | 1 | DAY 9 | 9 | 192 | DAY 1 DOSE | 192 | 192 | 192 | 8D | 192 | 2020-05-21 | 08:00 | 9 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 79.61 | 4.377099 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 79.61 | 79.61 | ||
| 42 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 10 | 1 | DAY 10 | 10 | 216 | DAY 1 DOSE | 216 | 216 | 216 | 9D | 216 | 2020-05-21 | 08:00 | 10 | 1 | DRUG (ng/mL) | 1 | 2 | 3.19 | 1.161523 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 3.19 | 3.19 | ||
| 43 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 10 | 1 | DAY 10 | 10 | 216 | DAY 1 DOSE | 216 | 216 | 216 | 9D | 216 | 2020-05-21 | 08:00 | 10 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 61.60 | 4.120669 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 61.60 | 61.6 | ||
| 44 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 11 | 1 | DAY 11 | 11 | 240 | DAY 1 DOSE | 240 | 240 | 240 | 10D | 240 | 2020-05-21 | 08:00 | 11 | 1 | DRUG (ng/mL) | 1 | 2 | 1.04 | 0.043502 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.04 | 1.04 | ||
| 45 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 11 | 1 | DAY 11 | 11 | 240 | DAY 1 DOSE | 240 | 240 | 240 | 10D | 240 | 2020-05-21 | 08:00 | 11 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 73.21 | 4.293272 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 73.21 | 73.21 | ||
| 46 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 MORNING DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-01-21 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | BLQ | ||
| 47 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 MORNING DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-01-21 | 07:54 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 128.37 | 4.854907 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 128.37 | 128.37 | ||
| 48 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0 | DAY 1 MORNING DOSE | 0 | 0 | 0 | DOSE | 0 | 2020-01-21 | 08:00 | 1 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | 1 | 1 | N | 50 | 50 | 50 | 12 | 7 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||||||||
| 49 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 MORNING DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-01-21 | 08:15 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 2.91 | 1.067237 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.91 | 2.91 | ||
| 50 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 MORNING DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-01-21 | 08:15 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 103.27 | 4.637362 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 103.27 | 103.27 | ||
| 51 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 MORNING DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-01-21 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 4.39 | 1.478924 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.39 | 4.39 | ||
| 52 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 MORNING DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-01-21 | 08:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 108.68 | 4.688433 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 108.68 | 108.68 | ||
| 53 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 MORNING DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-01-21 | 08:45 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.49 | 2.250409 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.49 | 9.49 | ||
| 54 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 MORNING DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-01-21 | 08:45 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 113.54 | 4.732154 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 113.54 | 113.54 | ||
| 55 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 MORNING DOSE | 1 | 1 | 1 | 1H | 1 | 2020-01-21 | 09:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 14.46 | 2.671443 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 14.46 | 14.46 | ||
| 56 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 MORNING DOSE | 1 | 1 | 1 | 1H | 1 | 2020-01-21 | 09:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 97.32 | 4.577994 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 97.32 | 97.32 | ||
| 57 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 MORNING DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-21 | 09:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 18.30 | 2.907014 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 18.30 | 18.3 | ||
| 58 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 MORNING DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-21 | 09:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 105.71 | 4.660707 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.71 | 105.71 | ||
| 59 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 MORNING DOSE | 2 | 2 | 2 | 2H | 2 | 2020-01-21 | 10:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 13.58 | 2.608391 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 13.58 | 13.58 | ||
| 60 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 MORNING DOSE | 2 | 2 | 2 | 2H | 2 | 2020-01-21 | 10:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 120.29 | 4.789945 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 120.29 | 120.29 | ||
| 61 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 MORNING DOSE | 3 | 3 | 3 | 3H | 3 | 2020-01-21 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 25.66 | 3.244865 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 25.66 | 25.66 | ||
| 62 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 MORNING DOSE | 3 | 3 | 3 | 3H | 3 | 2020-01-21 | 11:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 105.01 | 4.654081 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.01 | 105.01 | ||
| 63 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 MORNING DOSE | 4 | 4 | 4 | 4H | 4 | 2020-01-21 | 12:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 21.00 | 3.044436 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 21.00 | 21 | ||
| 64 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 MORNING DOSE | 4 | 4 | 4 | 4H | 4 | 2020-01-21 | 12:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 89.13 | 4.490147 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 89.13 | 89.13 | ||
| 65 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 MORNING DOSE | 6 | 6 | 6 | 6H | 6 | 2020-01-21 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 25.04 | 3.22044 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 25.04 | 25.04 | ||
| 66 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 MORNING DOSE | 6 | 6 | 6 | 6H | 6 | 2020-01-21 | 14:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 124.90 | 4.827486 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 124.90 | 124.9 | ||
| 67 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 MORNING DOSE | 8 | 8 | 8 | 8H | 8 | 2020-01-21 | 16:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 19.16 | 2.95296 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 19.16 | 19.16 | ||
| 68 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 MORNING DOSE | 8 | 8 | 8 | 8H | 8 | 2020-01-21 | 16:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 127.55 | 4.84854 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 127.55 | 127.55 | ||
| 69 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 MORNING DOSE | 12 | 12 | 12 | 12H | 12 | 2020-01-21 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 28.77 | 3.359384 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 28.77 | 28.77 | ||
| 70 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 MORNING DOSE | 12 | 12 | 12 | 12H | 12 | 2020-01-21 | 20:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 110.85 | 4.708191 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 110.85 | 110.85 | ||
| 71 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 2 | 2 | DAY 2 | 2 | 24 | DAY 1 AFTERNOON DOSE | 12 | 24 | 12 | PREDOSE | 0 | 2020-01-22 | 08:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 17.72 | 2.874591 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.72 | 17.72 | ||
| 72 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 2 | 2 | DAY 2 | 2 | 24 | DAY 1 AFTERNOON DOSE | 12 | 24 | 12 | PREDOSE | 0 | 2020-01-22 | 08:00 | 2 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 132.20 | 4.884353 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 132.20 | 132.2 | ||
| 73 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 3 | 3 | DAY 3 | 3 | 48 | DAY 2 AFTERNOON DOSE | 12 | 48 | 12 | PREDOSE | 0 | 2020-01-23 | 08:00 | 3 | 1 | DRUG (ng/mL) | 1 | 2 | 17.01 | 2.833753 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.01 | 17.01 | ||
| 74 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 3 | 3 | DAY 3 | 3 | 48 | DAY 2 AFTERNOON DOSE | 12 | 48 | 12 | PREDOSE | 0 | 2020-01-23 | 08:00 | 3 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 118.36 | 4.773765 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 118.36 | 118.36 | ||
| 75 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 4 | 4 | DAY 4 | 4 | 72 | DAY 3 AFTERNOON DOSE | 12 | 72 | 12 | PREDOSE | 0 | 2020-01-24 | 08:00 | 4 | 1 | DRUG (ng/mL) | 1 | 2 | 17.32 | 2.851861 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.32 | 17.32 | ||
| 76 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 4 | 4 | DAY 4 | 4 | 72 | DAY 3 AFTERNOON DOSE | 12 | 72 | 12 | PREDOSE | 0 | 2020-01-24 | 08:00 | 4 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 115.94 | 4.753035 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 115.94 | 115.94 | ||
| 77 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 95.9 | DAY 4 AFTERNOON DOSE | 11.06 | 96 | 12 | PREDOSE | 0 | 2020-01-25 | 07:54 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 17.32 | 2.851861 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.32 | 17.32 | ||
| 78 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 95.9 | DAY 4 AFTERNOON DOSE | 11.06 | 96 | 12 | PREDOSE | 0 | 2020-01-25 | 07:54 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 128.37 | 4.854907 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 128.37 | 128.37 | ||
| 79 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 95.9 | DAY 5 MORNING DOSE | 0 | 95.9 | 0 | DOSE | 0 | 2020-01-25 | 0.333333 | 5 | 2 | TEST PRODUCT (mg) | 0 | 1 | . | 1 | 1 | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | |||||||||||
| 80 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.25 | DAY 5 MORNING DOSE | 0.25 | 96.25 | 0.25 | 15MIN | 0.25 | 2020-01-25 | 08:15 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 19.91 | 2.991088 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 19.91 | 19.91 | ||
| 81 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.25 | DAY 5 MORNING DOSE | 0.25 | 96.25 | 0.25 | 15MIN | 0.25 | 2020-01-25 | 08:15 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 103.27 | 4.637362 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 103.27 | 103.27 | ||
| 82 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.5 | DAY 5 MORNING DOSE | 0.5 | 96.5 | 0.5 | 30MIN | 0.5 | 2020-01-25 | 08:30 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 21.39 | 3.06284 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 21.39 | 21.39 | ||
| 83 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.5 | DAY 5 MORNING DOSE | 0.5 | 96.5 | 0.5 | 30MIN | 0.5 | 2020-01-25 | 08:30 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 108.68 | 4.688433 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 108.68 | 108.68 | ||
| 84 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.75 | DAY 5 MORNING DOSE | 0.75 | 96.75 | 0.75 | 45MIN | 0.75 | 2020-01-25 | 08:45 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 26.49 | 3.276828 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 26.49 | 26.49 | ||
| 85 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.75 | DAY 5 MORNING DOSE | 0.75 | 96.75 | 0.75 | 45MIN | 0.75 | 2020-01-25 | 08:45 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 113.54 | 4.732154 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 113.54 | 113.54 | ||
| 86 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97 | DAY 5 MORNING DOSE | 1 | 97 | 1 | 1H | 1 | 2020-01-25 | 09:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 31.46 | 3.448743 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 31.46 | 31.46 | ||
| 87 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97 | DAY 5 MORNING DOSE | 1 | 97 | 1 | 1H | 1 | 2020-01-25 | 09:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 97.32 | 4.577994 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 97.32 | 97.32 | ||
| 88 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97.5 | DAY 5 MORNING DOSE | 1.5 | 97.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-25 | 09:30 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 35.30 | 3.563942 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 35.30 | 35.3 | ||
| 89 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97.5 | DAY 5 MORNING DOSE | 1.5 | 97.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-25 | 09:30 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 105.71 | 4.660707 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.71 | 105.71 | ||
| 90 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 98 | DAY 5 MORNING DOSE | 2 | 98 | 2 | 2H | 2 | 2020-01-25 | 10:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 30.58 | 3.420254 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 30.58 | 30.58 | ||
| 91 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 98 | DAY 5 MORNING DOSE | 2 | 98 | 2 | 2H | 2 | 2020-01-25 | 10:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 2120.29 | 4.789945 | 0 | 0 | 2000 | 10 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2120.29 | 2120.29 | ||
| 92 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 99 | DAY 5 MORNING DOSE | 3 | 99 | 3 | 3H | 3 | 2020-01-25 | 11:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 42.66 | 3.753221 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 42.66 | 42.66 | ||
| 93 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 99 | DAY 5 MORNING DOSE | 3 | 99 | 3 | 3H | 3 | 2020-01-25 | 11:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 105.01 | 4.654081 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.01 | 105.01 | ||
| 94 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 100 | DAY 5 MORNING DOSE | 4 | 100 | 4 | 4H | 4 | 2020-01-25 | 12:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 38.00 | 3.637538 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 38.00 | 38 | ||
| 95 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 100 | DAY 5 MORNING DOSE | 4 | 100 | 4 | 4H | 4 | 2020-01-25 | 12:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 89.13 | 4.490147 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 89.13 | 89.13 | ||
| 96 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 102 | DAY 5 MORNING DOSE | 6 | 102 | 6 | 6H | 6 | 2020-01-25 | 14:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 42.04 | 3.738601 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 42.04 | 42.04 | ||
| 97 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 102 | DAY 5 MORNING DOSE | 6 | 102 | 6 | 6H | 6 | 2020-01-25 | 14:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 124.90 | 4.827486 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 124.90 | 124.9 | ||
| 98 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 104 | DAY 5 MORNING DOSE | 8 | 104 | 8 | 8H | 8 | 2020-01-25 | 16:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 36.16 | 3.588025 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 36.16 | 36.16 | ||
| 99 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 104 | DAY 5 MORNING DOSE | 8 | 104 | 8 | 8H | 8 | 2020-01-25 | 16:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 127.55 | 4.84854 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 127.55 | 127.55 | ||
| 100 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 108 | DAY 5 MORNING DOSE | 12 | 108 | 12 | 12H | 12 | 2020-01-25 | 20:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 45.77 | 3.823661 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 45.77 | 45.77 | ||
| 101 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 108 | DAY 5 MORNING DOSE | 12 | 108 | 12 | 12H | 12 | 2020-01-25 | 20:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 110.85 | 4.708191 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 110.85 | 110.85 | ||
| 102 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 6 | 6 | DAY 6 | 6 | 120 | DAY 5 MORNING DOSE | 24 | 120 | 24 | 24H | 24 | 2020-01-26 | 08:00 | 6 | 2 | DRUG (ng/mL) | 1 | 2 | 17.30 | 2.8508 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.30 | 17.3 | ||
| 103 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 6 | 6 | DAY 6 | 6 | 120 | DAY 5 MORNING DOSE | 24 | 120 | 24 | 24H | 24 | 2020-01-26 | 08:00 | 6 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 110.99 | 4.709416 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 110.99 | 110.99 | ||
| 104 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 7 | 7 | DAY 7 | 7 | 144 | DAY 5 MORNING DOSE | 48 | 144 | 48 | 2D | 48 | 2020-01-27 | 08:00 | 7 | 2 | DRUG (ng/mL) | 1 | 2 | 3.32 | 1.199607 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 3.32 | 3.32 | ||
| 105 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 7 | 7 | DAY 7 | 7 | 144 | DAY 5 MORNING DOSE | 48 | 144 | 48 | 2D | 48 | 2020-01-27 | 08:00 | 7 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 114.20 | 4.737937 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 114.20 | 114.2 | ||
| 106 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 8 | 8 | DAY 8 | 8 | 168 | DAY 5 MORNING DOSE | 72 | 168 | 72 | 3D | 72 | 2020-01-28 | 08:00 | 8 | 2 | DRUG (ng/mL) | 1 | 2 | 3.69 | 1.306348 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 3.69 | 3.69 | ||
| 107 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 8 | 8 | DAY 8 | 8 | 168 | DAY 5 MORNING DOSE | 72 | 168 | 72 | 3D | 72 | 2020-01-28 | 08:00 | 8 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 126.20 | 4.837836 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 126.20 | 126.2 | ||
| 108 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 9 | 9 | DAY 9 | 9 | 192 | DAY 5 MORNING DOSE | 96 | 192 | 96 | 4D | 96 | 2020-01-29 | 08:00 | 9 | 2 | DRUG (ng/mL) | 1 | 2 | 4.33 | 1.466691 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.33 | 4.33 | ||
| 109 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 9 | 9 | DAY 9 | 9 | 192 | DAY 5 MORNING DOSE | 96 | 192 | 96 | 4D | 96 | 2020-01-29 | 08:00 | 9 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 117.41 | 4.765707 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 117.41 | 117.41 | ||
| 110 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 10 | 10 | DAY 10 | 10 | 216 | DAY 5 MORNING DOSE | 120 | 216 | 120 | 5D | 120 | 2020-01-30 | 08:00 | 10 | 2 | DRUG (ng/mL) | 1 | 2 | 4.71 | 1.550131 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.71 | 4.71 | ||
| 111 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 10 | 10 | DAY 10 | 10 | 216 | DAY 5 MORNING DOSE | 120 | 216 | 120 | 5D | 120 | 2020-01-30 | 08:00 | 10 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 90.86 | 4.509277 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 90.86 | 90.86 | ||
| 112 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 11 | 11 | DAY 11 | 11 | 240 | DAY 5 MORNING DOSE | 144 | 240 | 144 | 6D | 144 | 2020-01-31 | 08:00 | 11 | 2 | DRUG (ng/mL) | 1 | 2 | 0.00 | 0.43211 | 0 | 0 | 10000 | 1 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 0.00 | BLQ | ||
| 113 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 11 | 11 | DAY 11 | 11 | 240 | DAY 5 MORNING DOSE | 144 | 240 | 144 | 6D | 144 | 2020-01-31 | 08:00 | 11 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 107.97 | 4.68188 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 107.97 | 107.97 | ||
| 114 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | -0.1 | CYCLE 1 DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-09-21 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | LLOQ <= 1 | |||
| 115 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0 | CYCLE 1 DAY 1 DOSE | 0 | 0 | 0 | DOSE | 0 | 2020-09-21 | 08:00 | 1 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
| 116 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0.25 | CYCLE 1 DAY 1 DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-09-21 | 08:15 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 1.28 | 0.799881 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.28 | 1.28 | ||
| 117 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0.5 | CYCLE 1 DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-09-21 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 1.93 | 1.211567 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.93 | 1.93 | ||
| 118 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0.75 | CYCLE 1 DAY 1 DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-09-21 | 08:45 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 4.17 | 1.983053 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.17 | 4.17 | ||
| 119 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 1 | CYCLE 1 DAY 1 DOSE | 1 | 1 | 1 | 1H | 1 | 2020-09-21 | 09:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 6.37 | 2.404086 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 6.37 | 6.37 | ||
| 120 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 1.5 | CYCLE 1 DAY 1 DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-09-21 | 09:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 8.06 | 2.639658 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.06 | 8.06 | ||
| 121 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 2 | CYCLE 1 DAY 1 DOSE | 2 | 2 | 2 | 2H | 2 | 2020-09-21 | 10:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 5.97 | 2.341034 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 5.97 | 5.97 | ||
| 122 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 3 | CYCLE 1 DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2020-09-21 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 11.29 | 2.977508 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 11.29 | 11.29 | ||
| 123 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 4 | CYCLE 1 DAY 1 DOSE | 4 | 4 | 4 | 4H | 4 | 2020-09-21 | 12:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.24 | 2.777079 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.24 | 9.24 | ||
| 124 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 6 | CYCLE 1 DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2020-09-21 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 11.02 | 2.953083 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 11.02 | 11.02 | ||
| 125 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 8 | CYCLE 1 DAY 1 DOSE | 8 | 8 | 8 | 8H | 8 | 2020-09-21 | 16:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 8.44 | 2.685603 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.44 | 8.44 | ||
| 126 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 12 | CYCLE 1 DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2020-09-21 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.66 | 3.092027 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.66 | 12.66 | ||
| 127 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 2 | 2 | 23.917 | CYCLE 1 DAY 1 DOSE | 23.917 | 24 | 24 | 1D | 24 | 2020-09-22 | 07:55 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 7.80 | 2.607234 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 7.80 | 7.8 | ||
| 128 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 2 | 1 | 0 | CYCLE 1 DAY 2 DOSE | 0 | 24 | 0 | DOSE | 0 | 2020-09-22 | 08:00 | 2 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | |||||
| 129 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 1 | 1 | 24.45 | CYCLE 1 DAY 2 DOSE | 0.45 | 24.5 | 0.5 | 30MIN | 0.5 | 2020-09-22 | 08:27 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 2.28 | 0.824175 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.28 | 2.28 | ||
| 130 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 1 | 1 | 26 | CYCLE 1 DAY 2 DOSE | 2 | 26 | 2 | 2H | 2 | 2020-09-22 | 10:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 7.05 | 1.953028 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 7.05 | 7.05 | ||
| 131 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 1 | 1 | 32 | CYCLE 1 DAY 2 DOSE | 8 | 32 | 8 | 8H | 8 | 2020-09-22 | 16:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 9.95 | 2.297573 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.95 | 9.95 | ||
| 132 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 3 | 1 | CYCLE 1 DAY 3 | 1 | 48.17 | CYCLE 1 DAY 3 DOSE | 0 | 48 | 0 | DOSE | 0 | 2020-09-23 | 08:10 | 3 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
| 133 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 1 | 1 | CYCLE 2 DAY 1 | 1 | 264 | CYCLE 2 DAY 1 DOSE | 0 | 264 | 0 | DOSE | 0 | 2020-10-02 | 08:00 | 12 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 75 | 75 | 75 | 24 | 5 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 75 mg | 1 | TEST DRUG 75 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 75 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 75 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
| 134 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 7 | 1 | CYCLE 2 DAY 7 | 1 | 408 | CYCLE 2 DAY 7 DOSE | 0 | 408 | 0 | DOSE | 0 | 2020-10-08 | 08:00 | 18 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 24 | 9 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
| 135 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 17 | 1 | CYCLE 2 DAY 17 | 1 | 648 | CYCLE 2 DAY 17 DOSE | 0 | 648 | 0 | DOSE | 0 | 2020-10-18 | 08:00 | 28 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
| 136 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 671.83 | CYCLE 2 DAY 17 DOSE | -0.1 | 672 | 0 | PREDOSE | 0 | 2020-10-19 | 07:50 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 4.95 | 1.599388 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.95 | 4.95 | ||
| 137 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 672 | CYCLE 2 DAY 18 DOSE | 0 | 672 | 0 | DOSE | 0 | 2020-10-19 | 08:00 | 29 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | . | ||
| 138 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 672.5 | CYCLE 2 DAY 18 DOSE | 0.5 | 672.5 | 0.5 | 30MIN | 0.5 | 2020-10-19 | 08:30 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 8.03 | 2.083185 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.03 | 8.03 | ||
| 139 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 674 | CYCLE 2 DAY 18 DOSE | 2 | 674 | 2 | 2H | 2 | 2020-10-19 | 10:00 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 24.83 | 3.212053 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 24.83 | 24.83 | ||
| 140 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 680.33 | CYCLE 2 DAY 18 DOSE | 8 | 680 | 8 | 8H | 8 | 2020-10-19 | 16:20 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 35.05 | 3.556776 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 35.05 | 35.05 | ||
| 141 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | -0.1 | DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2021-01-07 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | LLOQ <= 1 | |||
| 142 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 0 | DAY 1 DOSE | 0 | 0 | 0 | DOSE | 0 | 2021-01-07 | 08:00 | 1 | 2021-01-07 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
| 143 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 0.5 | DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2021-01-07 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 14.76 | 2.691921 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 14.76 | 14.76 | ||
| 144 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 1.083 | DAY 1 DOSE | 1.083 | 1 | 1 | 1H | 1 | 2021-01-07 | 09:03 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 13.28 | 2.586259 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 13.28 | 13.28 | ||
| 145 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 3 | DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2021-01-07 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.53 | 2.528126 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 12.53 | 12.53 | ||
| 146 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 6 | DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2021-01-07 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 13.69 | 2.616666 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 13.69 | 13.69 | ||
| 147 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 8.167 | DAY 1 DOSE | 8.167 | 8 | 8 | 8H | 8 | 2021-01-07 | 16:06 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.32 | 2.511224 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 12.32 | 12.32 | ||
| 148 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 12 | DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2021-01-07 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 8.62 | 2.154085 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 8.62 | 8.62 | ||
| 149 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 24.5 | DAY 1 DOSE | 24.5 | 24 | 24 | 24H | 24 | 2021-01-08 | 08:30 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 6.34 | 1.846879 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 6.34 | 6.34 | ||
| 150 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 48 | DAY 1 DOSE | 48 | 48 | 48 | 48H | 48 | 2021-01-09 | 08:00 | 3 | 1 | DRUG (ng/mL) | 1 | 2 | 2.32 | 0.841567 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 2.32 | 2.32 | ||
| 151 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 72 | DAY 1 DOSE | 72 | 72 | 72 | 72H | 72 | 2021-01-10 | 08:00 | 4 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | LLOQ <= 1 | |||
| 152 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY14 | 2 | DAY14 | 2 | 336 | DAY 14 DOSE | 0 | 336 | 0 | DOSE | 0 | 2021-01-21 | 08:00 | 14 | 2021-01-21 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 72 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
| 153 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY15 | 3 | DAY15 | 3 | 360 | DAY 15 DOSE | 0 | 360 | 0 | DOSE | 0 | 2021-01-22 | 08:00 | 15 | 2021-01-22 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 24 | 5 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 72 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
| 154 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 503.9 | DAY 20 DOSE | -0.1 | 504 | 0 | PREDOSE | 0 | 2021-01-28 | 07:54 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 9.66 | 2.267994 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 72 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 9.66 | 9.66 | ||
| 155 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 504 | DAY 21 DOSE | 0 | 504 | 0 | DOSE | 0 | 2021-01-28 | 08:00 | 21 | 2021-01-28 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
| 156 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 504.583 | DAY 21 DOSE | 0.583 | 504.5 | 0.5 | 30MIN | 0.5 | 2021-01-28 | 08:36 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 24.288 | 3.189982 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 24.288 | 24.288 | ||
| 157 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 505 | DAY 21 DOSE | 1 | 505 | 1 | 1H | 1 | 2021-01-28 | 09:00 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 22.676 | 3.121307 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 22.676 | 22.676 | ||
| 158 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 507 | DAY 21 DOSE | 3 | 507 | 3 | 3H | 3 | 2021-01-28 | 11:00 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 21.398 | 3.063297 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 21.398 | 21.398 | ||
| 159 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 510.167 | DAY 21 DOSE | 6.167 | 510 | 6 | 6H | 6 | 2021-01-28 | 14:06 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 21.765 | 3.080303 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 21.765 | 21.765 | ||
| 160 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 512 | DAY 21 DOSE | 8 | 512 | 8 | 8H | 8 | 2021-01-28 | 16:00 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 19.867 | 2.98906 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 19.867 | 19.867 | ||
| 161 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 516.167 | DAY 21 DOSE | 12.167 | 516 | 12 | 12H | 12 | 2021-01-28 | 20:06 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 28.895 | 3.363669 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 28.895 | 28.895 | ||
| 162 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 528 | DAY 21 DOSE | 24 | 528 | 24 | 24H | 24 | 2021-01-29 | 08:00 | 22 | 1 | DRUG (ng/mL) | 1 | 2 | 15.11 | 2.715357 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 15.11 | 15.11 | ||
| 163 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 552 | DAY 21 DOSE | 48 | 552 | 48 | 48H | 48 | 2021-01-30 | 08:00 | 23 | 1 | DRUG (ng/mL) | 1 | 2 | 6.34 | 1.846879 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 6.34 | 6.34 | ||
| 164 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 578 | DAY 21 DOSE | 74 | 576 | 72 | 72H | 72 | 2021-01-31 | 10:00 | 24 | 1 | DRUG (ng/mL) | 1 | 2 | 2.32 | 0.841567 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 2.32 | 2.32 |