Dementia
Conditions
Keywords
EEG Standardization
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.
Interventions
DRUGMK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
DRUGComparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
DRUGComparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo | Baseline and 6 hours |
Secondary
| Measure | Time frame |
|---|---|
| EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo | Baseline and 2 hours |
Outcome results
None listed