Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20
研究概览
简要总结
This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 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 between the ages of 21 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m
- •Total body weight >45 kg (99 lbs).
排除标准
- •History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- •Known hypersensitivity or history of allergy to sulfonamides.
研究组 & 干预措施
Cohort 1
Twice daily regimen
干预措施: Maraviroc (Drug)
Cohort 1
Twice daily regimen
干预措施: Fosamprenavir/ritonavir (Drug)
Cohort 1
Twice daily regimen
干预措施: Maraviroc + Fosamprenavir/ritonavir (Drug)
Cohort 2
Once daily regimen
干预措施: Maraviroc (Drug)
Cohort 2
Once daily regimen
干预措施: Fosamprenavir/ritonavir (Drug)
Cohort 2
Once daily regimen
干预措施: Maraviroc + Fosamprenavir/ritonavir (Drug)
结局指标
主要结局
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20
时间窗: 25 days
Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20
时间窗: 25 days
次要结局
- Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.(25 days)
- Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.(25 days)
- Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.(25 days)