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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110616
• Other study ID #: 3134-010
• Secondary ID: MK3134-010
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2010
• Last updated: October 30, 2015
• Start date: June 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dementia

Intervention

Drug:
• MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
• Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
• Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo		Baseline and 6 hours	No
Secondary	EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo		Baseline and 2 hours	No