NCT00554762撤回1 期
A Phase I, Placebo Controlled, Randomised, Double Blind Two-way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- • Heat pain threshold at 5 hours post dose
研究概览
简要总结
The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects aged 18 to 50 years inclusive
- •Body Weight >50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
- •Women who are not of child bearing potential
排除标准
- •The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
- •A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
- •Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- •Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
结局指标
主要结局
• Heat pain threshold at 5 hours post dose
时间窗: 5 Hours
次要结局
- • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose.(5 Hours)
研究者
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