NCT00429728已完成1 期
An Open-Label, Parallel Group, Single Session Study Comparing the Pharmacokinetics of a Single Oral Dose of GW876008 Administered to Healthy Volunteer Smokers and Healthy Volunteer Non-Smokers.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.
研究概览
简要总结
This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females.
- •Normal ECG.
- •Non-smokers (abstinence from smoking for at least 6 months before the start of the study) or smokers who smoke between 10 and 30 cigarettes, inclusive, per day, for at least 2 months prior to screening.
- •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 clinically significant laboratory abnormality.
- •History of psychiatric illness.
- •Any history of suicidal attempts or behavior.
- •Active peptic ulcer disease.
- •Positive faecal occult blood.
- •Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs.
- •Female subjects who are currently or who are planning to become pregnant or who are lactating (from screening through at least 8 weeks after receiving study drug).
结局指标
主要结局
Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.
时间窗: on Day 1 at pre-dose and over 72 hours post-dose.
次要结局
- 12-lead ECG on day 1, 24 hours post dose, & follow up(on day 1, 24 hours post dose, & follow up)
- vital signs at screening & day 1 through 72 hours post dose(at screening & day 1 through 72 hours post dose)
- clinical laboratory data day 1 through 24 hours post dose(day 1 through 24 hours post dose)
- adverse events day 1 through 72 hours post dose(day 1 through 72 hours post dose)
研究者
研究点 (2)
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