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

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sequence 1; MK3134-Lorazepam-Placebo-MK3134-Lorazepam	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 2; MK3134-Lorazepam-Placebo-Lorazepam-MK3134	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 3; MK3134-Placebo-Lorazepam-MK3134-Lorazepam	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 4; MK3134-Placebo-Lorazepam-Lorazepam-MK3134	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 5; Lorazepam-Placebo-MK3134-MK3134-Lorazepam	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 6; Lorazepam-Placebo-MK3134-Lorazepam-MK3134	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 7; Lorazepam-MK3134-Placebo-MK3134-Lorazepam	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 8; Lorazepam-MK3134-Placebo-Lorazepam-MK3134	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 9; Placebo-MK3134-Lorazepam-MK3134-Lorazepam	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 10; Placebo-MK3134-Lorazepam-Lorazepam-MK3134	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 11; Placebo-Lorazepam-MK3134-MK3134-Lorazepam	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam
EXPERIMENTAL: Sequence 12; Placebo-Lorazepam-MK3134-Lorazepam-MK3134	Drug: MK3134; MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Drug: Comparator: Lorazepam; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Other Names: Lorazepam; Drug: Comparator: Placebo; Placebo, to match MK3134, and placebo to match Lorazepam

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (ESTIMATE): April 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 30, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: EEG Standardization
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Lorazepam
• Other Study ID Numbers: 3134-010; MK3134-010