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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01802476 | A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991) | PHASE1 | COMPLETED | 14 | — | — | May 1, 2013 | Jun 1, 2013 | Dec 17, 2013 | 1 | United Kingdom |
Dose-Normalized AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by the administered dose. It is obtained from AUC (0 - t) plus AUC (t - 8).
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 |
|---|---|---|
| Fixed Sequence Crossover Arm | OTHER | This study arm consists of a fixed sequence crossover where study subjects will receive Treatment A and following a washout of no less than 10 days will then receive Treatment B. The drug class is a CDK4/6 inhibitor. |
| Name | Type | Description |
|---|---|---|
| Oral Drug Formulation of PD-0332991 | DRUG | Treatment A consists of a single 125 mg oral dose of PD-0332991. |
| Intravenous Formulation of PD-0332991 | DRUG | Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate. |
Inclusion Criteria: 1. Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age. 2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs) Exclusion Criteria: 1. Any condition which could possibly affect drug...