An Up to Two-Part Relative Bioavailability Study of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets as Compared to the Reference Phase 2 Ad Hoc Combination Tablets in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)
研究概览
简要总结
This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers, 18 to 55 years of age
- •Body weight >/= 50.0 kg
- •Body mass index (BMI) 18.0 - 32.0 kg/m2
- •Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- •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, 1 of which must be a barrier method, 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
- •Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
- •Positive result 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
- •Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
- •Use of hormonal contraceptives (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication
- •Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
- •History of drug-related allergic reactions or hepatotoxicity
- •History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
研究组 & 干预措施
DNV + r reference
干预措施: danoprevir (Drug)
DNV + r reference
干预措施: ritonavir (Drug)
DNV/r fixed dose combination
干预措施: danoprevir (Drug)
DNV/r fixed dose combination
干预措施: ritonavir (Drug)
结局指标
主要结局
Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15
次要结局
- Safety: Incidence of adverse events(approximately 2 months)