NCT00934466已完成1 期
A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability 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
- 15
- 主要终点
- Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
研究概览
简要总结
This study will assess transcranial magnetic stimulation (TMS) as a biomarker and characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and dextromethorphan.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is right-handed
- •Subject is in good health
- •Subject is a nonsmoker
排除标准
- •Subject works a night shift
- •Subject has a history of any illness that might make participation in the study unsafe or confound the study results
- •Subject has a history of head injury
研究组 & 干预措施
1
Experimental
MK2637 120 mg
干预措施: MK2637 (Drug)
结局指标
主要结局
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
时间窗: 5 Hours after initial dosing
Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo
时间窗: 4 Hours after initial dosing
次要结局
- Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo(5 hours after initial dosing)
- Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo(6.5 hours after initial dosing)
研究者
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