NCT01597895已完成1 期
Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy 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
- 14
- 试验地点
- 1
- 主要终点
- Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10
研究概览
简要总结
The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m
- •Total body weight >50 kg (110 lbs).
排除标准
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).
研究组 & 干预措施
Maraviroc
Active Comparator
干预措施: Maraviroc (Drug)
Maraviroc + Boceprevir
Experimental
干预措施: Maraviroc + Boceprevir (Drug)
Maraviroc + Telaprevir
Experimental
干预措施: Maraviroc + Telaprevir (Drug)
结局指标
主要结局
Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10
时间窗: 25 days
次要结局
- Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10(25 days)
- Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10(10 days)
- Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10(10 days)
研究者
研究点 (1)
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