NCT00549211已完成1 期
A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs
研究概览
简要总结
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males who are 18 to 45 years of age
- •Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
- •Non-smokers
排除标准
- •Alcohol consumption averaging more than 7 drinks per week
- •Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
- •Any use of prescription drugs or non prescription drugs
结局指标
主要结局
Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs
时间窗: 24 Hours
次要结局
- Blood tests to study how long the drug stays in your blood(24 Hours)
研究者
研究点 (2)
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