NCT01514968已完成1 期
A Drug-Drug Interaction Study Between Danoprevir/Low-dose Ritonavir and Cyclosporine, a Potent Inhibitor of OATP, in Healthy Subjects
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
- 18
- 主要终点
- Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC)
研究概览
简要总结
This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy volunteers, 18 to 45 years of age inclusive
- •Body mass index (BMI) 18.0 to 32.0 kg/m2
- •Weight >/= 50 kg
- •Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- •Nonsmoker
- •Females of childbearing potential and males and their female partner(s) 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 (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)
排除标准
- •Pregnant or lactating females
- •Positive results for drugs of abuse in the urine 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 the first dose of study medication
- •Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
- •Routine chronic use of more than 2 g acetaminophen daily
- •Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
- •History of clinically significant disease or disorder
- •History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
- •History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)
研究组 & 干预措施
DNV/r+cyclosporine
Experimental
干预措施: cyclosporine (Drug)
DNV/r+cyclosporine
Experimental
干预措施: danoprevir (Drug)
DNV/r+cyclosporine
Experimental
干预措施: ritonavir (Drug)
cyclosporine
Active Comparator
干预措施: cyclosporine (Drug)
danoprevir+ritonavir
Active Comparator
干预措施: danoprevir (Drug)
danoprevir+ritonavir
Active Comparator
干预措施: ritonavir (Drug)
结局指标
主要结局
Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC)
时间窗: 16 time points up to 96 hours
次要结局
- Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine(16 time points up to 96 hours)
- Safety: Incidence of adverse events(approximately 50 days)
研究者
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