EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
- Registration Number
- NCT01110616
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 11 MK3134 Placebo-Lorazepam-MK3134-MK3134-Lorazepam Sequence 2 MK3134 MK3134-Lorazepam-Placebo-Lorazepam-MK3134 Sequence 5 MK3134 Lorazepam-Placebo-MK3134-MK3134-Lorazepam Sequence 6 MK3134 Lorazepam-Placebo-MK3134-Lorazepam-MK3134 Sequence 8 MK3134 Lorazepam-MK3134-Placebo-Lorazepam-MK3134 Sequence 7 MK3134 Lorazepam-MK3134-Placebo-MK3134-Lorazepam Sequence 9 MK3134 Placebo-MK3134-Lorazepam-MK3134-Lorazepam Sequence 3 MK3134 MK3134-Placebo-Lorazepam-MK3134-Lorazepam Sequence 10 MK3134 Placebo-MK3134-Lorazepam-Lorazepam-MK3134 Sequence 12 MK3134 Placebo-Lorazepam-MK3134-Lorazepam-MK3134 Sequence 1 MK3134 MK3134-Lorazepam-Placebo-MK3134-Lorazepam Sequence 4 MK3134 MK3134-Placebo-Lorazepam-Lorazepam-MK3134
- Primary Outcome Measures
Name Time Method EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo Baseline and 6 hours
- Secondary Outcome Measures
Name Time Method EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo Baseline and 2 hours