A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age.
- •A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs)
排除标准
- •Any condition which could possibly affect drug absorption.
- •Pregnancy or actively nursing females, or females of childbearing potential.
- •A positive urine drug screen.
研究组 & 干预措施
Fixed Sequence Crossover Arm
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.
干预措施: Intravenous Formulation of PD-0332991 (Drug)
Fixed Sequence Crossover Arm
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.
干预措施: Oral Drug Formulation of PD-0332991 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 0 to 144 hours
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).
Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 0 to 144 hours
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).
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 to 144 hours)
- Systemic Clearance (CL)(0 to 144 hours)
- Dose-Normalized Maximum Observed Plasma Concentration (Cmax)(0 to 144 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 to 144 hours)
- Maximum Observed Plasma Concentration (Cmax)(0 to 144 hours)
- Plasma Decay Half-Life (t1/2)(0 to 144 hours)
- Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 to 144 hours)
- Apparent Oral Clearance (CL/F)(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)