NCT00517673已完成1 期
A Two-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK945237 and the Effect of Food on Single Oral Doses of GSK945237 in Healthy Adult Subjects
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
- 68
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
GSK945237 is the first molecule of a new chemical class that is being developed for treatment of respiratory tract and other infections such as skin and soft tissue. This study drug has been tested in animals but has never been given to humans. This is a two part study. The purpose of the first part is to study the side effects of this drug in humans, and to study how much of the drug gets absorbed in the blood stream The second part of this study will compare absorption of the study drug in the blood stream when given with food and when given under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults between 18 and 60 years of age.
- •Body weight proportional to height.
- •Female subjects must be of non-childbearing potential.
- •QTc less than 450 msec at screening
排除标准
- •Any clinically relevant abnormality identified on the screening history and physical, or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or pre-dose.
- •A positive pre-study alcohol/urine drug screen.
- •Use of nicotine-containing products.
- •A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result.
- •Recent participation in another study, use of certain medications, consumption certain fruits, juices, or red wine
研究组 & 干预措施
GSK945237
Experimental
Active Study Drug
干预措施: GSK945237 (Drug)
Sugar Pill
Placebo Comparator
Placebo
干预措施: Sugar Pill (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Day 1 to follow-up visit
次要结局
- Pharmacokinetics(Day 1 to Day 5)
研究者
研究点 (1)
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