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

Primary Purpose

Dementia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK3134
Comparator: Lorazepam
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring EEG Standardization

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Sequence 1

    Sequence 2

    Sequence 3

    Sequence 4

    Sequence 5

    Sequence 6

    Sequence 7

    Sequence 8

    Sequence 9

    Sequence 10

    Sequence 11

    Sequence 12

    Arm Description

    MK3134-Lorazepam-Placebo-MK3134-Lorazepam

    MK3134-Lorazepam-Placebo-Lorazepam-MK3134

    MK3134-Placebo-Lorazepam-MK3134-Lorazepam

    MK3134-Placebo-Lorazepam-Lorazepam-MK3134

    Lorazepam-Placebo-MK3134-MK3134-Lorazepam

    Lorazepam-Placebo-MK3134-Lorazepam-MK3134

    Lorazepam-MK3134-Placebo-MK3134-Lorazepam

    Lorazepam-MK3134-Placebo-Lorazepam-MK3134

    Placebo-MK3134-Lorazepam-MK3134-Lorazepam

    Placebo-MK3134-Lorazepam-Lorazepam-MK3134

    Placebo-Lorazepam-MK3134-MK3134-Lorazepam

    Placebo-Lorazepam-MK3134-Lorazepam-MK3134

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 22, 2010
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01110616
    Brief Title
    EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
    Official Title
    A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    EEG Standardization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequence 1
    Arm Type
    Experimental
    Arm Description
    MK3134-Lorazepam-Placebo-MK3134-Lorazepam
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    MK3134-Lorazepam-Placebo-Lorazepam-MK3134
    Arm Title
    Sequence 3
    Arm Type
    Experimental
    Arm Description
    MK3134-Placebo-Lorazepam-MK3134-Lorazepam
    Arm Title
    Sequence 4
    Arm Type
    Experimental
    Arm Description
    MK3134-Placebo-Lorazepam-Lorazepam-MK3134
    Arm Title
    Sequence 5
    Arm Type
    Experimental
    Arm Description
    Lorazepam-Placebo-MK3134-MK3134-Lorazepam
    Arm Title
    Sequence 6
    Arm Type
    Experimental
    Arm Description
    Lorazepam-Placebo-MK3134-Lorazepam-MK3134
    Arm Title
    Sequence 7
    Arm Type
    Experimental
    Arm Description
    Lorazepam-MK3134-Placebo-MK3134-Lorazepam
    Arm Title
    Sequence 8
    Arm Type
    Experimental
    Arm Description
    Lorazepam-MK3134-Placebo-Lorazepam-MK3134
    Arm Title
    Sequence 9
    Arm Type
    Experimental
    Arm Description
    Placebo-MK3134-Lorazepam-MK3134-Lorazepam
    Arm Title
    Sequence 10
    Arm Type
    Experimental
    Arm Description
    Placebo-MK3134-Lorazepam-Lorazepam-MK3134
    Arm Title
    Sequence 11
    Arm Type
    Experimental
    Arm Description
    Placebo-Lorazepam-MK3134-MK3134-Lorazepam
    Arm Title
    Sequence 12
    Arm Type
    Experimental
    Arm Description
    Placebo-Lorazepam-MK3134-Lorazepam-MK3134
    Intervention Type
    Drug
    Intervention Name(s)
    MK3134
    Intervention Description
    MK3134, 25 mg tablets (5 x 5 mg capsule), orally
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Lorazepam
    Other Intervention Name(s)
    Lorazepam
    Intervention Description
    Lorazepam, 2 mg (2 x 1 mg tablet), orally
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo, to match MK3134, and placebo to match Lorazepam
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo
    Time Frame
    Baseline and 2 hours

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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