NCT01817985已完成1 期
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
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
- 33
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of GS-5816
研究概览
简要总结
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
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
- •Diagnosis of chronic (> 6 months), hepatic impairment.
- •In the opinion of the Investigator, be in good health.
排除标准
- •Severe hepatic encephalopathy.
- •Prior placement of a portosystemic shunt.
- •Hepatorenal or hepatopulmonary syndrome.
- •Suspicion of hepatocellular carcinoma.
研究组 & 干预措施
Cohort 1
Experimental
(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.
干预措施: GS-5816 (Drug)
Cohort 2
Experimental
(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.
干预措施: GS-5816 (Drug)
结局指标
主要结局
Pharmacokinetic parameters of GS-5816
时间窗: Up to one year
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
次要结局
- Incidences of adverse events and laboratory abnormalities(Up to one year)
研究者
研究点 (1)
Loading locations...
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