A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo
研究概览
简要总结
The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and lorazepam.
This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged across a topographical region of interest is decreased 6 hours after administration of MK3134 compared to placebo.
The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG using two probe compounds: MK3134 and lorazepam.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a male between 18 to 40 years of age
- •The subject has a Body Mass Index (BMI) greater than or equal to 31 kg/m^2 at the prestudy (screening) visit
- •Subject has normal or corrected to normal visual and auditory acuity
- •Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- •Subject is right-handed
排除标准
- •Subject has permanent cosmetic or metallic objects in their body that can interfere with the measurements
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of neoplastic disease
- •Subject has a current diagnosis of or a prior history of sleep apnea
- •Subject has a history of fainting during blood draws
- •Subject has a history of significant head injury/trauma
- •Subject has a current diagnosis of or history of Bipolar illness, Schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD), or claustrophobia
- •Subject works a night shift and is not able to avoid night shift work within 3 days before each treatment visit
- •Subject is currently a regular user of any illicit drugs or has a significant history of drug (including alcohol) abuse
研究组 & 干预措施
Sequence 12
Placebo-Lorazepam-MK3134-Lorazepam-MK3134
干预措施: MK3134 (Drug)
Sequence 5
Lorazepam-Placebo-MK3134-MK3134-Lorazepam
干预措施: MK3134 (Drug)
Sequence 2
MK3134-Lorazepam-Placebo-Lorazepam-MK3134
干预措施: MK3134 (Drug)
Sequence 6
Lorazepam-Placebo-MK3134-Lorazepam-MK3134
干预措施: MK3134 (Drug)
Sequence 11
Placebo-Lorazepam-MK3134-MK3134-Lorazepam
干预措施: MK3134 (Drug)
Sequence 10
Placebo-MK3134-Lorazepam-Lorazepam-MK3134
干预措施: MK3134 (Drug)
Sequence 9
Placebo-MK3134-Lorazepam-MK3134-Lorazepam
干预措施: MK3134 (Drug)
Sequence 8
Lorazepam-MK3134-Placebo-Lorazepam-MK3134
干预措施: MK3134 (Drug)
Sequence 7
Lorazepam-MK3134-Placebo-MK3134-Lorazepam
干预措施: MK3134 (Drug)
Sequence 4
MK3134-Placebo-Lorazepam-Lorazepam-MK3134
干预措施: MK3134 (Drug)
Sequence 3
MK3134-Placebo-Lorazepam-MK3134-Lorazepam
干预措施: MK3134 (Drug)
Sequence 1
MK3134-Lorazepam-Placebo-MK3134-Lorazepam
干预措施: MK3134 (Drug)
结局指标
主要结局
EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo
时间窗: Baseline and 6 hours
次要结局
- EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo(Baseline and 2 hours)