NCT00772512已完成1 期
Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effects Of PF-04802540 On Polysomnography Endpoints In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- REM sleep percentage
研究概览
简要总结
The purpose of this study is to determine if PF-04802540 decreases REM sleep.
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 male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive
- •Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight >45 kg (99 lbs)
- •Non-users of nicotine
排除标准
- •Evidence or history of clinically significant medical illness
- •A history of seizures, including childhood febrile seizures
- •Any condition possibly affecting drug absorption
研究组 & 干预措施
A
Experimental
干预措施: PF-04802540 (Drug)
B
Experimental
干预措施: PF-04802540 (Drug)
C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
REM sleep percentage
时间窗: 1 day
次要结局
- REM sleep latency(1 day)
- Beta EEG power(1 day)
- Plasma concentrations of PF-04802540 and its metabolite, PF-04831035(2 days)
研究者
研究点 (1)
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