NCT01433575已完成1 期
A Single-center, Open-label, Single Dose, Randomized, Two-way Cross-over Study to Investigate the Pharmacokinetics, Safety, and Tolerability of RO4917838 in Healthy Chinese 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
- 16
- 主要终点
- Pharmacokinetics: Area under the concentration-time curve (AUC)
研究概览
简要总结
This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
- •Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
- •Body mass index (BMI) 19 to 28 kg/m2 inclusive
排除标准
- •Pregnant or currently lactating females
- •History of any clinically relevant disorder
- •Any history of depressive episodes or treatment with antidepressants
- •History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
- •Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
- •Positive for HIV, hepatitis B or hepatitis C infection
- •Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
- •Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing
- •Medical history of significant drug allergies
研究组 & 干预措施
A
Experimental
干预措施: RO4917838 (Drug)
B
Experimental
干预措施: RO4917838 (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration-time curve (AUC)
时间窗: 12 days
Pharmacokinetics: Peak plasma concentrations (Cmax)
时间窗: 12 days
次要结局
- Safety: Incidence of adverse events(approximately 4 months)
研究者
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