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

NCT01110616 | Completed Phase 1

• 2 other identifiers: 3134-010MK3134-010
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dementia

Keywords

EEG Standardization

Outcome Measures

Primary Outcomes (1)

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

  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

  Baseline and 2 hours

Study Arms (12)

Sequence 1

EXPERIMENTAL

MK3134-Lorazepam-Placebo-MK3134-Lorazepam

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 2

EXPERIMENTAL

MK3134-Lorazepam-Placebo-Lorazepam-MK3134

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 3

EXPERIMENTAL

MK3134-Placebo-Lorazepam-MK3134-Lorazepam

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 4

EXPERIMENTAL

MK3134-Placebo-Lorazepam-Lorazepam-MK3134

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 5

EXPERIMENTAL

Lorazepam-Placebo-MK3134-MK3134-Lorazepam

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 6

EXPERIMENTAL

Lorazepam-Placebo-MK3134-Lorazepam-MK3134

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 7

EXPERIMENTAL

Lorazepam-MK3134-Placebo-MK3134-Lorazepam

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 8

EXPERIMENTAL

Lorazepam-MK3134-Placebo-Lorazepam-MK3134

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 9

EXPERIMENTAL

Placebo-MK3134-Lorazepam-MK3134-Lorazepam

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 10

EXPERIMENTAL

Placebo-MK3134-Lorazepam-Lorazepam-MK3134

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 11

EXPERIMENTAL

Placebo-Lorazepam-MK3134-MK3134-Lorazepam

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Sequence 12

EXPERIMENTAL

Placebo-Lorazepam-MK3134-Lorazepam-MK3134

Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo

Interventions

MK3134 DRUG

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

Sequence 1; Sequence 10; Sequence 11; Sequence 12; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6; Sequence 7; Sequence 8; Sequence 9

Comparator: Lorazepam DRUG

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

Also known as: Lorazepam

Sequence 1; Sequence 10; Sequence 11; Sequence 12; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6; Sequence 7; Sequence 8; Sequence 9

Comparator: Placebo DRUG

Placebo, to match MK3134, and placebo to match Lorazepam

Sequence 1; Sequence 10; Sequence 11; Sequence 12; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6; Sequence 7; Sequence 8; Sequence 9

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Dementia

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 26, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 2, 2015

Record last verified: 2015-10