A Phase 1, Open-Label Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Rifampin On Palbociclib (PD-0332991) Pharmacokinetics In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 15
- 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 will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 males or females of non-childbearing potential
- •body mass index between 17.5-30.5 kg/m2 with a total body weight greater than 50kg
排除标准
- •Evidence or history of any clinically significant physiologic, psychological, or medical conditions
- •a positive drug screen or alcohol breath test
- •a baseline ECG demonstrating a QTc>450msecs or a QRS interval >120msecs
研究组 & 干预措施
Single-Arm Fixed-Sequence
Subjects will receive two different interventions in fixed-sequence two-period study. In the first period the subjects will receive a single-dose of palbociclib. In the second period, subjects will receive 12 days of rifampin and a single dose of palbociclib on day 8. In both periods, subjects will undergo pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.
干预措施: Palbociclib (Drug)
Single-Arm Fixed-Sequence
Subjects will receive two different interventions in fixed-sequence two-period study. In the first period the subjects will receive a single-dose of palbociclib. In the second period, subjects will receive 12 days of rifampin and a single dose of palbociclib on day 8. In both periods, subjects will undergo pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.
干预措施: Rifampin (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 post-dose
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 post-dose
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0-120 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0-120 hours post-dose)
- Plasma Decay Half-Life (t1/2)(0-120 hours post-dose)
- Apparent Oral Clearance (CL/F)(0-120 hours post-dose)
- Apparent Volume of Distribution (Vz/F)(0-120 hours post-dose)