NCT02196636已完成1 期
A Single-center, Randomised, Double-blind, Adaptative, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics or RO6806127 in Healthy Male 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
- 37
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.
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
- •Healthy male participants aged 18 to 45 years, inclusive
- •A BMI between 18 to 30 kg/m2, inclusive
- •Agreement to use highly effective contraception
排除标准
- •Clinically significant abnormalities in laboratory test results
- •History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
- •Significant disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- •Use of any prohibited medications and food before study start and during the study
- •Dietary restrictions that would prohibit the consumption of standardized meals
研究组 & 干预措施
Part 1: Single Ascending Dose (SAD)
Experimental
Adaptive model per protocol
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose (SAD)
Experimental
Adaptive model per protocol
干预措施: RO6806127 (Drug)
Part 2: Food Effect (FE)
Experimental
Fasted versus Fed
干预措施: Placebo (Drug)
Part 2: Food Effect (FE)
Experimental
Fasted versus Fed
干预措施: RO6806127 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to Day 21
次要结局
- RO6806127 metabolite concentrations in selected plasma and urine samples(Up to Day 21)
- Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine(Up to Day 21)
- Relative bioavailability (food effect): Area under the concentration-time curves [AUC](Up to Day 21)
研究者
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