EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
NCT ID: NCT01110616
Last Updated: 2015-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2010-06-30
2010-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sequence 1
MK3134-Lorazepam-Placebo-MK3134-Lorazepam
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 2
MK3134-Lorazepam-Placebo-Lorazepam-MK3134
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 3
MK3134-Placebo-Lorazepam-MK3134-Lorazepam
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 4
MK3134-Placebo-Lorazepam-Lorazepam-MK3134
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 5
Lorazepam-Placebo-MK3134-MK3134-Lorazepam
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 6
Lorazepam-Placebo-MK3134-Lorazepam-MK3134
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 7
Lorazepam-MK3134-Placebo-MK3134-Lorazepam
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 8
Lorazepam-MK3134-Placebo-Lorazepam-MK3134
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 9
Placebo-MK3134-Lorazepam-MK3134-Lorazepam
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 10
Placebo-MK3134-Lorazepam-Lorazepam-MK3134
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 11
Placebo-Lorazepam-MK3134-MK3134-Lorazepam
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Sequence 12
Placebo-Lorazepam-MK3134-Lorazepam-MK3134
MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Interventions
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MK3134
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: Placebo
Placebo, to match MK3134, and placebo to match Lorazepam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
40 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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MK3134-010
Identifier Type: -
Identifier Source: secondary_id
3134-010
Identifier Type: -
Identifier Source: org_study_id
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