NCT01543529已完成1 期
A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol 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
- 25
- 试验地点
- 1
- 主要终点
- Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
研究概览
简要总结
This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers, 18 to 45 years, inclusive
- •Body Mass Index (BMI) 18 to 30 kg/m2, inclusive
- •Non-smoker or smoker of fewer than 10 cigarettes per day
- •Females, who are not menopausal must agree to use two adequate methods of contraception
排除标准
- •Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk
- •History of alcoholism
- •History of drug abuse and/or addiction within one year of study start
- •History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
研究组 & 干预措施
RO4917838 + alcohol
Experimental
干预措施: Alcohol (Other)
RO4917838 + non-alcoholic drink
Active Comparator
干预措施: RO4917838 (Drug)
RO4917838 + alcohol
Experimental
干预措施: RO4917838 (Drug)
RO4917838 placebo + alcohol
Placebo Comparator
干预措施: Placebo to RO4917838 (Drug)
RO4917838 placebo + alcohol
Placebo Comparator
干预措施: Alcohol (Other)
RO4917838 placebo + non-alcoholic drink
Placebo Comparator
干预措施: Placebo to RO4917838 (Drug)
结局指标
主要结局
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
时间窗: Day 1 of each treatment period
次要结局
- Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838(Days 1, 2, 3, 4, 6, and 8 of each treatment period)
- Safety: Incidence of adverse events(Approximately 4 months)
研究者
研究点 (1)
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