Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)

Study Overview
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Brief Summary
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This study will assess transcranial magnetic stimulation (TMS) as a biomarker and characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and dextromethorphan.

Official Title
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A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: MK2637
* Drug: Comparator: MK2637
* Drug: Comparator: Placebo
* Drug: Comparator: Dextromethorphan
* Drug: Comparator: Dextromethorphan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is right-handed Subject is in good health Subject is a nonsmoker Exclusion Criteria: Subject works a night shift Subject has a history of any illness that might make participation in the study unsafe or confound the study results Subject has a history of head injury

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK2637 120 mg | Drug: MK2637<br>* Single dose of 120 mg MK2637 capsules in one of five treatment periods.<br>|
| Experimental: 2<br>MK2637 50 mg | Drug: Comparator: MK2637<br>* Single dose of 50 mg MK2637 capsules in one of five treatment periods.<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Comparator: Placebo<br>* Single dose of placebo only in one of five treatment periods.<br>|
| Active Comparator: 4<br>Dextromethorphan 220 mg | Drug: Comparator: Dextromethorphan<br>* Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.<br>|
| Active Comparator: 5<br>Dextromethorphan 110 mg | Drug: Comparator: Dextromethorphan<br>* Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo |  | 5 Hours after initial dosing | 
| Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo |  | 4 Hours after initial dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo |  | 6.5 hours after initial dosing | 
| Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo |  | 5 hours after initial dosing |