NCT01625806已完成1 期
A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 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
- 34
- 主要终点
- Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC)
研究概览
简要总结
This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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 subjects, 18 to 45 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- •Body mass index (BMI) 18 to 30 kg/m2 inclusive
- •Male subjects and their partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 90 days after the last dose
- •Non-smoker (not having smoked since at least 3 months prior to screening)
排除标准
- •History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- •Positive for hepatitis B, hepatitis C, or HIV infection
- •Participation in an investigational drug or device study within 90 days prior to screening
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •History of any disease or condition that could alter the absorption, metabolism or elimination of drugs
- •Positive drug test and/or positive alcohol test
- •Positive cotinine test
- •Subject likely to need concomitant medication during the study period (including for dental conditions)
- •Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
研究组 & 干预措施
RO4602522
Active Comparator
干预措施: RO4602522 (Drug)
RO4602522 + ketoconazole
Experimental
干预措施: RO4602522 (Drug)
RO4602522 + ketoconazole
Experimental
干预措施: ketoconazole (Drug)
结局指标
主要结局
Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
次要结局
- Safety: Incidence of adverse events(approximately 3 months)
- RO4602522 metabolites: Plasma/urine concentrations(Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22)
研究者
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