NCT00559884已完成1 期
An Open-label, Randomized, Single Dose, Crossover Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Modified Release Formulations of GSK189075 in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Blood samples:
研究概览
简要总结
The purpose of this research study is to look at concentrations of GSK189075 in blood when different long and short acting forms of the drug are taken by mouth. The results will help to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the body and safety will also be studied.
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
- None
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
- •Are a healthy, non-smoking adult, 18 to 55 years old.
- •Are not overly thin or overly heavy for your height.
- •Are a female who is unable to have children, or is willing to use birth control throughout the study.
- •Are willing and able to follow all study-related instructions provided by the site staff. - Are willing to provide signed consent.
排除标准
- •Are a pregnant or a nursing female.
- •Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
- •Have had certain infections within 4 weeks before the expected the first dose of study drug.
- •Have HIV or hepatitis, or have alcohol in your system at the screening visit.
- •Have a history of alcohol abuse.
- •Have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
- •Have laboratory tests that are outside the normal range.
结局指标
主要结局
Blood samples:
时间窗: collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood
Urine:
时间窗: collected over 24-hour period after dosing with each form to measure amount of urine produced & amount of sugar in urine
次要结局
- Adverse events:(all visits after Day -1)
- blood pressure & heart rate:(screening,Day -1 - Day 1,follow-up visit)
- ECGs:(screening,pre-dose, Day 1)
- lab tests:(screening, Day -1 - Day 1,follow-up)
研究者
研究点 (2)
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