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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dementia

Intervention: MK3134 (Drug); Comparator: Lorazepam (Drug); Comparator: Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: June 2010
Last updated: November 4, 2014

Page last updated: August 23, 2015

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