A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Effect Of Food On The Bioavailability Of Palbociclib
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 28
- 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
This study is intended to quantify the effect of food on the extent of absorption of palbociclib.
The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug.
High and low calorie meals will be given to the subjects 30 minutes before palbociclib administration as 2 of the 3 conditions to compare with completely absence of food in the body when dosing (fasted).The third condition to test and compare with fasted stage will be the administration of food before and after palbociclib administration.
This information will help the program to decide wether or not the presence of food when dosing palbociclib help with its absorption and to what extent it does help. Based on the collected information, a recommendation about the administration of palbociclib with food will be provided to patients.
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 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 (or a legal representative) has been informed of all pertinent aspects of the study
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Any condition possibly affecting drug absorption
- •Male subjects who are unwilling or unable to use a highly effective method of contraception
研究组 & 干预措施
Palbociclib given to healthy volunteers
干预措施: Palbociclib administered Fasted (Drug)
Palbociclib given to healthy volunteers
干预措施: Palbociclib administered Fed high calorie (Drug)
Palbociclib given to healthy volunteers
干预措施: Palbociclib administered Fed low calorie (Drug)
Palbociclib given to healthy volunteers
干预措施: Palbociclib administered Fed moderate calorie (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: 144 hrs
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).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 144 hrs
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(144 hrs)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](144 hrs)
- Area under the Concentration-Time Curve (AUC) from 0 to 72 hrs(144 hrs)
- Apparent Oral Clearance (CL/F)(144 hrs)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(144 hrs)
- Apparent Volume of Distribution (Vz/F)(144 hrs)
- Plasma Decay Half-Life (t1/2)(144 hrs)