NCT00513565已完成1 期
A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects
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
- 22
- 试验地点
- 1
- 主要终点
- Differences in fMRI brain activation (BOLD) response in specific brain regions
研究概览
简要总结
This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Non-smokers
- •Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
- •Normal ECG.
排除标准
- •Any serious medical disorder or condition.
- •Any history of an endocrine disorder.
- •Any clinically significant laboratory abnormality.
- •History of psychiatric illness.
- •Any history of suicidal attempts or behavior.
- •History or current diagnosis of acute narrow angle glaucoma.
- •Left handed
研究组 & 干预措施
lorazepam arm
Active Comparator
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
干预措施: single dose (Drug)
placebo arm
Placebo Comparator
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
干预措施: single dose (Drug)
GSK561679 arm
Experimental
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
干预措施: single dose (Drug)
结局指标
主要结局
Differences in fMRI brain activation (BOLD) response in specific brain regions
时间窗: conducted the duration of the study
次要结局
- Vital signs & ECG recording(duration of the study)
- Visual Analogue Scale measurement of physical reactions(duration of study)
- Lab tests for blood & urine(throughout the study)
- Physiologic changes(during & after fMRI session)
- Blood level of GSK561679(collected during fMRI session)
研究者
研究点 (1)
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