EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Lorazepam

Criteria

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