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Completed

NCT Number: NCT01110616

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK3134

Drug

MK3134, 25 mg tablets (5 x 5 mg capsule), orally

Comparator: Lorazepam

Drug

Lorazepam, 2 mg (2 x 1 mg tablet), orally

Other names: Lorazepam

Comparator: placebo

Drug

Placebo, to match MK3134, and placebo to match Lorazepam

Primary outcomes

  1. EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo

    Time frame: Baseline and 6 hours

Secondary outcomes

  1. EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo

    Time frame: Baseline and 2 hours

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2010
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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