NCT01654211已完成1 期
A Three-Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low-Dose Ritonavir (RTV), the Absolute Bioavailability of DNV With and Without Oral Low-Dose RTV, and the Effect of Oral Cyclosporine on IV DNV/Oral Low-Dose RTV in Healthy Adult Volunteers
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
- 33
- 主要终点
- Pharmacokinetics: Area under the concentration-time curve (AUC)
研究概览
简要总结
This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
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
- •Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; 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
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
研究组 & 干预措施
Part 2 A: iv danoprevir
Experimental
干预措施: danoprevir (Drug)
Part 1: iv danoprevir
Experimental
干预措施: danoprevir (Drug)
Part 1: iv danoprevir
Experimental
干预措施: ritonavir (Drug)
Part 1: placebo
Placebo Comparator
干预措施: placebo (Drug)
Part 1: placebo
Placebo Comparator
干预措施: ritonavir (Drug)
Part 2 A: iv danoprevir
Experimental
干预措施: ritonavir (Drug)
Part 2 B: oral danoprevir
Active Comparator
干预措施: danoprevir (Drug)
Part 2 B: oral danoprevir
Active Comparator
干预措施: ritonavir (Drug)
Part 2 C: ritonavir
Active Comparator
干预措施: ritonavir (Drug)
Part 3 D: iv danoprevir
Experimental
干预措施: danoprevir (Drug)
Part 3 D: iv danoprevir
Experimental
干预措施: ritonavir (Drug)
Part 3 E: iv danoprevir + cyclosporine
Experimental
干预措施: danoprevir (Drug)
Part 3 E: iv danoprevir + cyclosporine
Experimental
干预措施: ritonavir (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 12 hours post-dose
Safety: Incidence of adverse events
时间窗: approximately 7 months
次要结局
未报告次要终点
研究者
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