NCT00435695已完成1 期
An Open Label, Non-randomized Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain 5-HT1A Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK163090, Using the Ligand [11C]-WAY100635.
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
- 13
- 试验地点
- 1
- 主要终点
- Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090
研究概览
简要总结
The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called [11C]-WAY100635.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 male subjects, aged 18-45 years Body weight > 50 kg
- •Non-Smoker
- •Normal ECG, heart rate and blood pressure
排除标准
- •History of any cardiac disease
- •History of regular alcohol consumption averaging >14 drinks/week
- •Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
- •Positive for Hepatitis B and C, and HIV.
- •History of drug abuse.
- •Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
- •Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
- •Suffers from claustrophobia
- •History or presence of neurological or psychiatric conditions
- •Presence of a cardiac pacemaker or other implanted electronic device or metal implants
研究组 & 干预措施
GSK163090
Active Comparator
one infusion only
干预措施: GSK163090 (Drug)
结局指标
主要结局
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090
时间窗: throughout the study
次要结局
- Vitals signs ECGs Clinical Laboratory test results(throughout the study)
研究者
研究点 (1)
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