A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib In Healthy Subjects To Investigate The Potential Effect Of Antacid Treatment On The Pharmacokinetics Of A Single Oral Dose 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
- 26
- 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
Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption process of Palbociclib.
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
- •Female subjects of non-childbearing potential; Healthy subjects identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test.
排除标准
- •A positive urine drug screen, urine cotinine test or alcohol breath test.
- •Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication. All antacid agents must be discontinued 28 days prior to the first dose of study medication.
研究组 & 干预措施
Fixed sequence crossover
All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole.
干预措施: Palbociclib alone (Drug)
Fixed sequence crossover
All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole.
干预措施: Palbociclib + Rabeprazole (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: 0-120 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).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-120 hours
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](0-120 hours)
- Area Under the Curve from Time Zero to 72 hours(0-72 hours)
- Apparent Oral Clearance (CL/F)(0-120 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0-120 hours)
- Time For the Last Quantifiable Concentration (Tlast)(0-120 hours)
- Apparent Volume of Distribution (Vz/F)(0-120 hours)
- Plasma Decay Half-Life (t1/2)(0-120 hours)