A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Renal Function and Severe Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 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, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.
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 79 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 severe renal impairment:
- •Stable chronic kidney disease
- •Creatinine clearance (CLcr) < 30 mL/min
排除标准
- •All individuals:
- •Pregnant or nursing female or male with pregnant female partner
- •Hepatitis B virus, hepatitis C virus (HCV) or 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 severe renal impairment:
- •Anticipated to require dialysis within 90 days of study dosing
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Normal Renal Function
Participants will receive a single dose of voxilaprevir on Day 1.
干预措施: Voxilaprevir (Drug)
Severe Renal Impairment
Participants 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 (predose ≤ 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
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
- Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities(First dose date to Day 31)