A Phase 1 Placebo-controlled, Randomized, Observer-blind Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5271983 in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Single ascending dose (SAD): Safety (incidence of adverse events)
研究概览
简要总结
This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Healthy volunteers, 18-65 years of age
- •Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
- •In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception
排除标准
- •A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
- •Clinical significant abnormalities in laboratory test results
- •Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
- •Smokers of >5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study
研究组 & 干预措施
1
干预措施: RO5271983 - SAD (Drug)
2
干预措施: RO5271983 - MAD (Drug)
3
干预措施: Placebo - SAD (Drug)
4
干预措施: Placebo - MAD (Drug)
结局指标
主要结局
Single ascending dose (SAD): Safety (incidence of adverse events)
时间窗: 14 weeks
Single ascending dose (SAD): Tolerability (e.g. vital signs)
时间窗: 14 weeks
Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
时间窗: 8 weeks
Multiple ascending doses (MAD): Safety (incidence of adverse events)
时间窗: 8 weeks
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
时间窗: 17 days
Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
时间窗: up to 240 hours
次要结局
- Effect of food on pharmacokinetics of RO5271983(up to 240 hours)
- Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983(72 hours)
- Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983(14 days)