A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study In Healthy Volunteers To Estimate The Effect Of Active Pharmaceutical Ingredient Particle Size And Lubrication On The Bioavailability Of A Single 125 Mg Dose Of Palbociclib (PD-0332991) Administered Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 with no physical possibility of getting pregnant.
- •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 (eg, gastrectomy).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) preceding the first dose of study medication.
- •Pregnant females; breastfeeding females; females with physical possibility of getting pregnant .
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 2 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
时间窗: 7 days
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time
时间窗: 7 days
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(7 days)
- Apparent Oral Clearance (CL/F)(7 days)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(2 days)
- Area under the Concentration-Time Curve (AUC) from 0 to 72(3 days)
- Plasma Decay Half-Life (t1/2)(7 days)
- Apparent Volume of Distribution (Vz/F)(7 days)