NCT01367756已完成1 期
A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration 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
- 32
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
- •Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
- •Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
- •Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
- •Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug
排除标准
- •Pregnant or lactating females
- •Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
- •Hepatitis B, hepatitis C or HIV infection
- •Smokers of >5 cigarettes or equivalent tobacco intake per day
- •Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
- •Participation in an investigational drug or device study within 3 months prior to dosing
研究组 & 干预措施
1
Experimental
干预措施: RO4995819 (Drug)
1
Experimental
干预措施: citalopram (Drug)
2
Placebo Comparator
干预措施: citalopram (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: up to 58 days
次要结局
- Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram(17 days)
- Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram(up to 58 days)
研究者
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