NCT00439959终止1 期
A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK625433 in Healthy Subjects and in Subjects Who Are Chronically Infected With Hepatitis C.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety parameters: adverse events; telemetry; clinical laboratory values, vital signs, and ECGs. Plasma levels of GSK625433. Change in HCV viral load. Taken throughout the study
研究概览
简要总结
This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males & females
- •Part 1 ages 18-60
- •Part 2 ages 18-50 & 65-80
- •Within normal weight range given your height
- •Negative urine drug and alcohol test
- •Willing to follow all study procedures
排除标准
- •Any significant abnormal lab, ECG, medical or physical exam finding during screening
- •Allergy to the study drug
- •Excessive alcohol intake
- •Positive HIV or hepatitis B or C result
- •Use of prescription or non-prescription drugs within one week of study start except for birth control
- •Blood pressure meds & Tylenol
- •Pregnant or lactating women
结局指标
主要结局
Safety parameters: adverse events; telemetry; clinical laboratory values, vital signs, and ECGs. Plasma levels of GSK625433. Change in HCV viral load. Taken throughout the study
时间窗: 17 Days
次要结局
- Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study(17 Days)
研究者
研究点 (1)
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