← Trials/Trial dossier/NCT01110616

CompletedPhase 1

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

Lead sponsor

Merck Sharp & Dohme LLC

Asset

MK3134

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criteria

•Age 18-40•Male

Primary endpoint

•EEG theta power averaged across a topographical region of interest 6 hours

Identifiers

Registered as

Org study ID3134-010

SecondaryMK3134-010

NCT IDNCT01110616

Timeline

Milestones

Study first posted2010-04-26estimated

Study start2010-06 (month precision)

Primary completion2010-10actual (month precision)

Study completion2010-10actual (month precision)

Last update posted2015-11-02estimated

Assets

Drug assets

MK3134

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexMale

Healthy volunteersAccepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Fluid / digital biomarkers

2 endpoints

Primary/protocol endpoint

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

Time frame:Baseline and 6 hours

ratio, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline and 2 hours

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.