Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804
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
- 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
Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication
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 subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •An informed consent document signed and dated by the subject.
排除标准
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.
研究组 & 干预措施
Fasted
Dacomitinib administered under fasted conditions
干预措施: dacomitinib fasted (Drug)
Fed
Dacomitinib administered under fed conditions
干预措施: dacomitinib fed (Drug)
Antacid
Dacomitinib administered under antacid treatment
干预措施: dacomitinib+antacid (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: 2 weeks
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). For dacomitinib and PF-05199265
Maximum Observed Plasma Concentration (Cmax)
时间窗: 2 weeks
For dacomitinib and PF-05199265
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](2 weeks)
- Area under the Concentration-Time Curve (AUC)(3 days)
- Apparent Oral Clearance (CL/F)(2 weeks)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(2 weeks)
- Apparent Volume of Distribution (Vz/F)(2 weeks)
- Plasma Decay Half-Life (t1/2)(2 weeks)