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

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects

Conditions
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Dementia

Intervention / Treatment
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* Drug: MK3134
* Drug: Comparator: Lorazepam
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>MK3134-Lorazepam-Placebo-MK3134-Lorazepam | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 2<br>MK3134-Lorazepam-Placebo-Lorazepam-MK3134 | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 3<br>MK3134-Placebo-Lorazepam-MK3134-Lorazepam | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 4<br>MK3134-Placebo-Lorazepam-Lorazepam-MK3134 | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 5<br>Lorazepam-Placebo-MK3134-MK3134-Lorazepam | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 6<br>Lorazepam-Placebo-MK3134-Lorazepam-MK3134 | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 7<br>Lorazepam-MK3134-Placebo-MK3134-Lorazepam | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 8<br>Lorazepam-MK3134-Placebo-Lorazepam-MK3134 | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 9<br>Placebo-MK3134-Lorazepam-MK3134-Lorazepam | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 10<br>Placebo-MK3134-Lorazepam-Lorazepam-MK3134 | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 11<br>Placebo-Lorazepam-MK3134-MK3134-Lorazepam | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|
| Experimental: Sequence 12<br>Placebo-Lorazepam-MK3134-Lorazepam-MK3134 | Drug: MK3134<br>* MK3134, 25 mg tablets (5 x 5 mg capsule), orally<br>Drug: Comparator: Lorazepam<br>* Lorazepam, 2 mg (2 x 1 mg tablet), orally<br>* Other names: Lorazepam;Drug: Comparator: Placebo<br>* Placebo, to match MK3134, and placebo to match Lorazepam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo |  | Baseline and 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo |  | Baseline and 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG Standardization