NCT00522808终止1 期
A Clinical Pharmacology Study to Determine the Pharmacokinetic , Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of A-831 in Otherwise Healthy Male Hepatitis C Carriers With Compensated Liver Disease
Arrow Therapeutics5 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Antiviral activity
研究概览
简要总结
The purposes of this study are:
- to determine the safety and tolerability of multiple doses of A-831 at various doses
- to determine how multiple doses of A-831 are distributed through the bloodstream
- to determine if A-831 reduces the amount of Hepatitis C virus in the blood
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical
- •Volunteers who have given their written informed consent to participate in the study
- •Volunteers who are willing and able to comply with the protocol and study procedures
- •Volunteers who have a diagnosis of chronic hepatitis C infection and are in good health (other than history of Hepatitis C infection)
排除标准
- •Voulnteers with concurrent medical conditions or taking concurrent medications
结局指标
主要结局
Antiviral activity
Safety
PK
Tolerability
次要结局
未报告次要终点
研究者
研究点 (5)
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