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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dementia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110616

MK3134-010

3134-010

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 12 patient groups

Sequence 1

Experimental group

Description:

MK3134-Lorazepam-Placebo-MK3134-Lorazepam

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 2

Experimental group

Description:

MK3134-Lorazepam-Placebo-Lorazepam-MK3134

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 3

Experimental group

Description:

MK3134-Placebo-Lorazepam-MK3134-Lorazepam

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 4

Experimental group

Description:

MK3134-Placebo-Lorazepam-Lorazepam-MK3134

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 5

Experimental group

Description:

Lorazepam-Placebo-MK3134-MK3134-Lorazepam

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 6

Experimental group

Description:

Lorazepam-Placebo-MK3134-Lorazepam-MK3134

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 7

Experimental group

Description:

Lorazepam-MK3134-Placebo-MK3134-Lorazepam

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 8

Experimental group

Description:

Lorazepam-MK3134-Placebo-Lorazepam-MK3134

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 9

Experimental group

Description:

Placebo-MK3134-Lorazepam-MK3134-Lorazepam

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 10

Experimental group

Description:

Placebo-MK3134-Lorazepam-Lorazepam-MK3134

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 11

Experimental group

Description:

Placebo-Lorazepam-MK3134-MK3134-Lorazepam

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134

Sequence 12

Experimental group

Description:

Placebo-Lorazepam-MK3134-Lorazepam-MK3134

Treatment:

Drug: Comparator: Lorazepam

Drug: Comparator: Placebo

Drug: MK3134