NCT00423761已完成1 期
An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy 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
- 25
- 试验地点
- 2
- 主要终点
- Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
研究概览
简要总结
This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Healthy males or females.
- •Normal ECG.
- •Agree to remain in the clinic for the time defined in the protocol.
- •Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.
排除标准
- •Any serious medical disorder or condition.
- •Any history of an endocrine disorder.
- •Any clinically significant laboratory abnormality.
- •History of psychiatric illness.
- •Any history of suicidal attempts or behavior.
- •Active peptic ulcer disease.
- •Positive faecal occult blood.
- •The subject smokes or has smoked or has used any nicotine-containing products in the last six months.
- •Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
结局指标
主要结局
Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
时间窗: on Day 1 of Session 1 and on Days 1 and 14 of Session 2.
次要结局
- vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2(day 1 session 1; days 1, 7 & 14 session 2)
- 12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2(day 1 session 1; days 1 & 14 session 2)
研究者
研究点 (2)
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