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Also known as Oral Drug Formulation of PD-0332991
Drug Formulation of PD-0332991 · 1 trial · 1 indication
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...
The Drug Formulation of PD-0332991 is an oral formulation of palbociclib, a small molecule developed by Pfizer, Inc. (ticker PFE). It was studied in a Phase 1 trial comparing plasma drug exposure from an oral dose against an intravenous dose. The formulation is also known as the Oral Drug Formulation of PD-0332991.
Pfizer, Inc., which trades under the ticker PFE, is the developer of the Drug Formulation of PD-0332991. Pfizer sponsored the clinical work evaluating this oral formulation of palbociclib, including the Phase 1 study that compared oral and intravenous dosing of the compound.
The Drug Formulation of PD-0332991 has been studied in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials of this formulation are currently active. It is an investigational formulation and is not described as approved.
The Drug Formulation of PD-0332991 was evaluated in trial NCT01802476, titled A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991). The Phase 1 trial enrolled 14 healthy volunteers in the United Kingdom and has completed.
Yes. The Drug Formulation of PD-0332991 and the Oral Drug Formulation of PD-0332991 refer to the same asset, an oral formulation of palbociclib developed by Pfizer, Inc. The two names describe the same Phase 1 small molecule formulation studied in healthy volunteers.
The Drug Formulation of PD-0332991 was tested in a single completed Phase 1 trial, NCT01802476, that compared plasma drug exposure after an oral dose versus an intravenous dose of palbociclib. The study enrolled 14 healthy volunteers in the United Kingdom, was uncontrolled, and was not randomized or double blinded.