NCT01893437已完成1 期
A Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6799477 Following Oral Administration of Single Ascending Doses 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
- 27
- 主要终点
- Part 1: Safety: Incidence of adverse events
研究概览
简要总结
This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy volunteers, aged 18-45 years, inclusive
- •Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.
- •Body Mass index (BMI) of 18-30 kg/m2, inclusive
排除标准
- •Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C
- •Positive testing for drugs of abuse
- •Any history of alcohol and/or drug of abuse addiction
研究组 & 干预措施
Single oral dose group
Experimental
干预措施: RO6799477 (Drug)
结局指标
主要结局
Part 1: Safety: Incidence of adverse events
时间窗: 18 weeks
次要结局
- Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477(Pre-dose, Day 1, 2, 3, 4)
研究者
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