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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01110616
• Date of registration: 22/04/2010
• Primary sponsor: Merck
• Public title: EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
• Scientific title: A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects
• Date of first enrolment: June 2010
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01110616
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Belgium

Contacts

• Name: Medical Monitor
• Affiliation: Merck

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Dementia

Intervention(s)

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Primary Outcome(s)

EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo [Time Frame: Baseline and 6 hours]

Secondary Outcome(s)

EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo [Time Frame: Baseline and 2 hours]

Secondary ID(s)

2010_529

MK3134-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors