A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose
研究概览
简要总结
This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers, 18 - 60 years of age
- •Female subjects must be surgically sterile or post-menopausal
- •Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
- •Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)
排除标准
- •History or evidence of any clinically significant disease or disorder
- •Pregnant or lactating women
- •Male partners of women who are lactating or trying to become pregnant
- •Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
- •Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Participation in an investigational drug, biologic, or device study within three months before first study drug administration
研究组 & 干预措施
A
干预措施: moxifloxacin placebo (Drug)
A
干预措施: danoprevir (Drug)
A
干预措施: ritonavir (Drug)
B
干预措施: danoprevir (Drug)
B
干预措施: moxifloxacin placebo (Drug)
B
干预措施: ritonavir (Drug)
C
干预措施: danoprevir placebo (Drug)
C
干预措施: moxifloxacin (Drug)
C
干预措施: ritonavir placebo (Drug)
D
干预措施: danoprevir placebo (Drug)
D
干预措施: moxifloxacin placebo (Drug)
D
干预措施: ritonavir placebo (Drug)
结局指标
主要结局
Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose
时间窗: approximately 9 weeks
次要结局
- Pharmacokinetics: Plasma concentrations(approximately 9 weeks)
- Cardiac response: Electrocardiogram (ECG)(approximately 9 weeks)
- Safety: Incidence of adverse events(approximately 9 weeks)
- Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes(approximately 9 weeks)