A Phase 1, Open Label Study To Investigate The Effect Of Dose And Ethnicity On Palbociclib (PD-0332991) Pharmacokinetics In Japanese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 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 investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, this study will investigate the effect of Japanese ethnicity of palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects must be a healthy male or female of non-childbearing potential
- •Subjects must have a BMI (Body Mass Index) between 17.5 and 30.5 kg/m2
- •To be eligible for the Japanese cohort, subjects must have 4 biological grandparents who are Japanese that were born in Japan
排除标准
- •Any condition affecting drug absorption (eg gastrectomy, achlorhydria, etc)
- •Use of prescription or non-prescription drugs
- •A QTc-interval >450msec or a QRS interval >120msec
- •Pregnant or breastfeeding females, females of childbearing potential, and males who are unwilling or unable to use an effective method of contraception for the duration of the study and for 90 days after the last dose of palbociclib in the study
研究组 & 干预措施
Healthy Subjects of Japanese Descent
Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods.
干预措施: Palbociclib 75mg (Drug)
Healthy Subjects of Japanese Descent
Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods.
干预措施: Palbociclib 125mg (Drug)
Healthy Subjects of Japanese Descent
Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods.
干预措施: Palbociclib 100mg (Drug)
Healthy Subjects of Japanese Descent
Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods.
干预措施: Palbociclib (Drug)
Healthy Non-Asian Subjects
Enrolled healthy non-Asian subjects will receive a single 125mg oral dose of palbociclib in a single treatment period.
干预措施: Palbociclib 125mg (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).
Dose-normalised Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 0-120 hours
AUC (0 - 8)DN= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by dose. It is obtained from AUC (0 - t) plus AUC (t - 8) all divided by the administered dose.
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-120 hours
Dose-Normalised Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-120 hours
次要结局
- Plasma Decay Half-Life (t1/2)(0-120 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0-120 hours)
- Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0-120 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0-120 hours)
- Apparent Oral Clearance (CL/F)(0-120 hours)
- Apparent Volume of Distribution (Vz/F)(0-120 hours)