NCT01747941已完成1 期
A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,
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
- 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 young subjects
- •aged 18-55
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
Cohort 3
Experimental
Single ascending oral doses in fed conditions
干预措施: PF-06305591 (Drug)
Cohort 1
Experimental
Single ascending oral doses in fasted conditions
干预措施: PF-06305591 (Drug)
Cohort 1
Experimental
Single ascending oral doses in fasted conditions
干预措施: Placebo (Drug)
Cohort 2
Experimental
Single ascending oral doses in fasted conditions
干预措施: PF-06305591 (Drug)
Cohort 2
Experimental
Single ascending oral doses in fasted conditions
干预措施: Placebo (Drug)
Cohort 3
Experimental
Single ascending oral doses in fed conditions
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 72 hr
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)](72 hr)
研究者
研究点 (1)
Loading locations...
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