A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- C max: maximum observed plasma concentration
研究概览
简要总结
This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, 18 to 65 years of age, inclusive
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive
- •All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
- •Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.
排除标准
- •Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
- •Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
- •Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
- •Any confirmed allergic reaction against any drug or multiple allergies
- •Dietary restrictions that would prohibit the consumption of standardized meals
- •Positive cotinine test and/or any use of nicotine containing products
- •Clinically relevant history of constipation or bowel disorder
- •Known intolerability to activated charcoal
研究组 & 干预措施
2
干预措施: RO4995819 (Drug)
1
干预措施: RO4995819 (Drug)
1
干预措施: activated charcoal (Drug)
结局指标
主要结局
C max: maximum observed plasma concentration
时间窗: 18 weeks
T max: time of maximum observed plasma concentration
时间窗: 18 weeks
T1/2: apparent terminal half-life
时间窗: 18 weeks
AUC: area under the plasma concentration-time curve
时间窗: 18 weeks
次要结局
未报告次要终点