A Phase 1, Open-Label, Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Single Dose Pharmacokinetics of Palbociclib (PD-0332991) In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 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 designed to evaluate the potential effect of itraconazole on the pharmacokinetics 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
- •Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- •Body mass index of 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs).
- •Evidence of a personally signed and dated informed consent document indicating that the subject 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 diseases.
- •Any condition possibly affecting drug absorption.
- •A positive urine drug screen or alcohol breath test.
- •Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
研究组 & 干预措施
Fixed sequence
Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole)
干预措施: Palbociclib Alone (Drug)
Fixed sequence
Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole)
干预措施: Palbociclib plus itraconazole (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 to 168 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 to 168 hours
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 to 168 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 to 168 hours)
- Plasma Decay Half-Life (t1/2)(0 to 168 hours)
- Apparent Oral Clearance (CL/F)(0 to 168 hours)
- Apparent Volume of Distribution (Vz/F)(0 to 168 hours)