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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02041273 | Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions | PHASE1 | COMPLETED | 36 | — | — | Jan 1, 2014 | Mar 1, 2014 | Mar 17, 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 |
|---|---|---|
| Palbociclib given to healthy volunteers | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| palbociclib isethionate (phase 1 and 2 studies) | DRUG | 125 mg palbociclib isethionate salt under overnight fasting conditions |
| palbociclib commercial free base capsule | DRUG | 125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal) |
Inclusion Criteria: * Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years. * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Exclusion...