NCT00605241已完成1 期
A Randomized, Double-bind, Placebo Controlled, Two-way Cross-over Study to Assess the Effects of a Single Dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward
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
- 29
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male smokers aged 18-65 with a desire to quit smoking.
- •Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
- •Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.
排除标准
- •Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
- •History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
- •History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
- •History of cardiac or pulmonary disease/abnormalities.
研究组 & 干预措施
GSK598809
Other
Drug
干预措施: GSK598809 (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: through 24 hours
次要结局
- Stroop test(through 10 hours)
研究者
研究点 (1)
Loading locations...
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