NCT00314054已完成1 期
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 27 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
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
- •Men and women of non-childbearing potential.
- •Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
- •Healthy volunteers: healthy as determined by the investigator.
排除标准
- •History of alcoholism within 1 year.
- •Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
- •Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.
研究组 & 干预措施
1
Experimental
HCV-796 1000mg single dose
干预措施: HCV-796 (Drug)
结局指标
主要结局
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
时间窗: 7 days
次要结局
- To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults(15 days)
研究者
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