Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02097329 | Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food | PHASE1 | COMPLETED | 27 | — | — | Apr 1, 2014 | Jun 1, 2014 | Jun 19, 2014 | 1 | United States |
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Palbociclib under fed conditions | EXPERIMENTAL | - |
| Cohort 2: Palbociclib under fed conditions | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| palbociclib commercial free base | DRUG | 125 mg oral capsule single dose |
| famotidine | DRUG | 20 mg oral tablet 10 hours before and 2 hours after palbociclib |
| rabeprazole | DRUG | 2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib |
| antacid | DRUG | 30 mL orally once (2h before palbociclib) |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Willing and able to comply with all scheduled visits, treatment plan, l...