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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01110616
First received: April 22, 2010
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Dementia
Drug: MK3134
Drug: Comparator: Lorazepam
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo [ Time Frame: Baseline and 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo [ Time Frame: Baseline and 2 hours ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
MK3134-Lorazepam-Placebo-MK3134-Lorazepam
Drug: MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: 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
Other Name: MK3134
Drug: Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Other Name: Lorazepam
Drug: Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110616

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01110616     History of Changes
Other Study ID Numbers: 2010_529, MK3134-010
Study First Received: April 22, 2010
Last Updated: January 27, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Merck Sharp & Dohme Corp.:
EEG Standardization

Additional relevant MeSH terms:
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014