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

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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