NCT01714154已完成1 期
A Multi Center, Sequential, Open-Label, Multiple-Dose Study of Setrobuvir (STV) Alone and With Co-Administration of Ritonavir-boosted Danoprevir to Evaluate the Safety, Tolerability and Pharmacokinetics of STV, DNV, and Ritonavir (RTV) in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
研究概览
简要总结
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults, 18-65 years of age, inclusive
- •Weight >/= 45.0 kg
- •Body mass index (BMI) 18.0 - 35.0 kg/m2, inclusive
- •Females of childbearing potential and males and their female partners of childbearing potential must agree to use two forms of non-hormonal contraception as defined by protocol
- •Subjects with a history of substance abuse may be enrolled provided they have not abused drugs or alcohol for at least 6 months
- •Healthy subjects only:
- •Medical history without major recent or ongoing pathology Laboratory values at screening and Day -1 within the normal range or showing no clinically relevant deviations
- •Subjects with hepatic impairment only:
- •Stable mild liver disease (Child-Pugh A) of cryptogenic, post-hepatic, hepatitis B/C, or alcoholic origin Stable hepatic impairment defined as no clinically significant change in disease status within the last 30 days Must be on stable dose of medication and/or treatment regimen at least 2 weeks before dosing of study medication
排除标准
- •Pregnant or lactating women or males with female partners who are pregnant or lactating
- •Active infection or febrile illness </= 10 days prior to the first dose of study medication
- •Uncontrolled/untreated hypertension
- •Inadequate renal function
- •Positive urine drug screen or positive breath alcohol test at screening and on Day -1 of each period
- •An average alcohol intake of more than 2 units per day or 14 units per week until 48 hours prior to enrollment
- •History of any significant drug-related allergy or hepatotoxicity
- •Participation in other clinical studies with an investigational drug or new chemical entity within 3 months (6 months for biologic therapies) prior to the first dose of study medication
- •Positive for HIV infection
- •Any clinically significant cardiovascular or cerebrovascular disease
- •Healthy subjects only:
- •Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, absorption of medication, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Positive screening test for HBsAg or HCV antibody
- •Subjects with hepatic impairment only:
- •Severe ascites at screening or Day -1 History of or current severe hepatic encephalopathy (Grade 3 or higher) Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver Positive screening test for HCV antigen
研究组 & 干预措施
A: setrobuvir
Experimental
干预措施: setrobuvir (Drug)
B: setrobuvir + DNV/r
Experimental
干预措施: danoprevir (Drug)
B: setrobuvir + DNV/r
Experimental
干预措施: ritonavir (Drug)
B: setrobuvir + DNV/r
Experimental
干预措施: setrobuvir (Drug)
结局指标
主要结局
Pharmacokinetics: Plasma concentration at steady-state 12 hours post-dose (Css, 12h)
时间窗: up to 16 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
时间窗: up to 16 days
Safety: Incidence of adverse events
时间窗: approximately 40 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state (AUCss,0-12h)
时间窗: up to 16 days
次要结局
- Pharmacokinetics: Apparent oral clearance at steady-state (CLss/F)(up to 16 days)
- Pharmacokinetics: Cumulative amount excreted at steady-state (Aess)(up to 16 days)
- Pharmacokinetics of danoprevir in combination with setrobuvir: Area under the concentration-time curve (AUC)(up to 12 days)
- Pharmacokinetics: Elimination half-life (t1/2)(up to 16 days)
- Pharmacokinetics: Time to maximum plasma concentration (tmax)(up to 16 days)
- Pharmacokinetics: Fraction of orally administered drug excreted into urine (fe/f)(up to 16 days)
- Pharmacokinetics of ritonavir in combination with setrobuvir: Area under the concentration-time curve (AUC)(up to 12 days)
研究者
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