A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All individuals:
- •Screening laboratory values within defined thresholds for group
- •Use of two effective contraception methods if female of childbearing potential or sexually active male
- •For individuals with moderate hepatic impairment:
- •Diagnosis of chronic (> 6 months) hepatic impairment
- •Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh Class B).
- •For individuals with severe hepatic impairment:
- •Diagnosis of chronic (> 6 months) hepatic impairment
- •Score on the CPT scale of 10-15 at screening (Child Pugh Class C)
- •For individuals with normal hepatic function:
- •Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative
排除标准
- •All individuals:
- •Pregnant or nursing female or male with pregnant female partner
- •HIV infection
- •History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
- •For individuals with moderate or severe hepatic impairment:
- •Active HCV infection
- •Current hepatic encephalopathy
- •Variceal bleeding in the last 6 months unless banded
- •Prior placement of a portosystemic shunt
- •History of hepatorenal or hepatopulmonary syndrome
- •Spontaneous bacterial peritonitis currently or within the last 6 months
- •Hospitalization within the last 2 months related to cirrhosis
- •Confirmed hypotension
- •Suspicion of hepatocellular carcinoma
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Moderate Hepatic Impaired
Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
干预措施: Voxilaprevir (Drug)
Severe Hepatic Impaired
Participants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
干预措施: Voxilaprevir (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
时间窗: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
PK Parameter of Voxilaprevir: AUCinf
时间窗: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.
PK Parameter of Voxilaprevir: Cmax
时间窗: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Cmax is defined as the maximum observed plasma concentration of drug.Data presented are unadjusted geometric means and confidence intervals.
次要结局
未报告次要终点