A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
研究概览
简要总结
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 18-55 years of age
- •BMI of 17.5-30.5 kg/m2
排除标准
- •History of drug or alcohol abuse within 2 years of screening
- •Subjects without suitable veins for multiple venipuncture/cannulation
研究组 & 干预措施
PF-06427878
干预措施: PF-06427878 (Drug)
结局指标
主要结局
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)
时间窗: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Terminal Elimination Half Life (t1/2)
时间窗: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Systemic Clearance (CL)
时间窗: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Volume of Distribution at Steady State (Vss)
时间窗: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
次要结局
- Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)(Day 1 Hr 0 to 12.5)
- Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)(Day 1 Hr 0 to 12.5)
- Renal clearance (CLr)(Day 1 Hr 0 to 12.5)