NCT01664143已完成1 期
A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy 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
- 入组人数
- 36
- 主要终点
- Safety: incidence of adverse events
研究概览
简要总结
This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers, >/=18 years of age
- •Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- •Use of adequate contraception methods or surgically sterile
排除标准
- •Evidence of active or chronic disease
- •Regular consumption of drugs of abuse
- •Regular smoker (>5 cigarettes per day)
- •Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
- •History of significant allergic reactions
- •Abnormal blood pressure
- •Clinical significant abnormalities (e.g., cardiovascular, laboratory values)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO5508887
Experimental
干预措施: RO5508887 (Drug)
结局指标
主要结局
Safety: incidence of adverse events
时间窗: 30 days
次要结局
- Correlation of the age on pharmacokinetics of RO5508887(30 days)
- Pharmacokinetics: plasma levels of RO5508887(Predose and up to 144 hours post last dose, and at follow-up)
- Correlation of the age on pharmacodynamics of RO5508887(30 days)
- Pharmacodynamics: Plasma levels of amyloid deposition markers(Predose and up to 144 hours post last dose)
- Correlation of the age on safety of RO5508887(30 days)
研究者
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