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| ID | Type | Description | Link |
|---|---|---|---|
| QBR115052 |
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The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Drug Formulation of PD-0332991 | Drug | Treatment A consists of a single 125 mg oral dose of PD-0332991. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 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). | 0 to 144 hours |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 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). | 0 to 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0 to 144 hours |
| Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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. |
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by the administered dose. |
| 0 to 144 hours |
| Maximum Observed Plasma Concentration (Cmax) | 0 to 144 hours |
| Dose-Normalized Maximum Observed Plasma Concentration (Cmax) | The maximum observed plasma concentration divided by the administered dose. | 0 to 144 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 to 144 hours |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0 to 144 hours |
| Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body following an intravenous dose. | 0 to 144 hours |
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0 to 144 hours |
| Apparent Volume of Distribution after an Oral Dose (Vz/F) | 0 to 144 hours |
| Volume of Distribution at Steady State after an IV Infusion (Vss) | 0 to 144 hours |