A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Apparent Volume of Distribution (Vz/F)
研究概览
简要总结
The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
研究组 & 干预措施
Experimental: Cohort A
Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.
干预措施: PF-06291874 (Drug)
Experimental: Cohort A
Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.
干预措施: placebo (Other)
结局指标
主要结局
Apparent Volume of Distribution (Vz/F)
时间窗: 0-72/dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0-72/dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]
时间窗: 0-72/dose
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-72/dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0-72/dose
Plasma Decay Half-Life (t1/2)
时间窗: 0-72/dose
Apparent Oral Clearance (CL/F)
时间窗: 0-72/dose
次要结局
未报告次要终点