NCT01059578已完成1 期
A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK206136 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin-1 Receptor Occupancy
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
- 33
- 试验地点
- 1
- 主要终点
- Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2
研究概览
简要总结
This is the first study in humans with GSK206136 to evaluate what effects: good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males aged 18-45 years, limited to 25-40 years of age for PET section
排除标准
- •The subject has a positive: drug/alcohol, Hepatitis, HIV screen..
- •The subject has a history of psychiatric illness suicidal attempts or behaviour.
- •Abuse of alcohol.
- •Clinically significant laboratory, ECG abnormality;
- •The subject has recently received an investigational.
- •Use of prescription or non-prescription drugs,
- •History or presence of allergy to the study drug or drugs of this class,
- •Donation of more than 500 mL blood within the 90 days before dosing.
- •An unwillingness of male subjects to comply with contraceptive requirements
- •Average daily caffeine intake exceeding Protocol requirements.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo once daily
干预措施: PLACEBO (Drug)
Active
Experimental
GSK206136 once daily
干预措施: GSK206136 (Drug)
Active
Experimental
GSK206136 once daily
干预措施: PET (Radiation)
结局指标
主要结局
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); pharmacokinetics parameters: AUC, Cmax, t1/2
时间窗: 12 weeks
次要结局
- Brain receptor occupancy(2 weeks)
研究者
研究点 (1)
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