A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
研究概览
简要总结
This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 18 to 45 years of age inclusive
- •Body mass index 18.0 - 32.0 kg/m2, weight >/= 50 kg
- •Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- •Non-smoker
- •Medical history without major, recent or ongoing pathology
- •Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration
排除标准
- •Pregnant or lactating women or males with female partners who are pregnant or lactating
- •Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
- •Routine use of more than 2 g of acetaminophen daily
- •History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
- •History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
- •History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
- •Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
研究组 & 干预措施
Part 2 E
干预措施: danoprevir (Drug)
Part 2 E
干预措施: ritonavir (Drug)
Part 2 F
干预措施: danoprevir (Drug)
Part 2 F
干预措施: ritonavir (Drug)
Part 2 D
干预措施: danoprevir (Drug)
Part 2 D
干预措施: ritonavir (Drug)
Part 1 A
干预措施: danoprevir (Drug)
Part 1 A
干预措施: ritonavir (Drug)
Part 1 B
干预措施: danoprevir (Drug)
Part 1 B
干预措施: ritonavir (Drug)
Part 1 C
干预措施: danoprevir (Drug)
Part 1 C
干预措施: ritonavir (Drug)
结局指标
主要结局
Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
时间窗: 24 hours
Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)
时间窗: 24 hours
Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC)
时间窗: 24 hours
Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC)
时间窗: 24 hours
次要结局
- Safety: Incidence of adverse events(approximately 4 months)