Back to resultsStudy of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK2637
Comparator: MK2637
Comparator: Placebo
Comparator: Dextromethorphan
Comparator: Dextromethorphan
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
5
Arm Description
MK2637 120 mg
MK2637 50 mg
Placebo
Dextromethorphan 220 mg
Dextromethorphan 110 mg
Outcomes
Primary Outcome Measures
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo
Secondary Outcome Measures
Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00934466
Brief Title
Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
Official Title
A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MK2637 120 mg
Arm Title
2
Arm Type
Experimental
Arm Description
MK2637 50 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
4
Arm Type
Active Comparator
Arm Description
Dextromethorphan 220 mg
Arm Title
5
Arm Type
Active Comparator
Arm Description
Dextromethorphan 110 mg
Intervention Type
Drug
Intervention Name(s)
MK2637
Intervention Description
Single dose of 120 mg MK2637 capsules in one of five treatment periods.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK2637
Intervention Description
Single dose of 50 mg MK2637 capsules in one of five treatment periods.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Single dose of placebo only in one of five treatment periods.
Intervention Type
Drug
Intervention Name(s)
Comparator: Dextromethorphan
Intervention Description
Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.
Intervention Type
Drug
Intervention Name(s)
Comparator: Dextromethorphan
Intervention Description
Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.
Primary Outcome Measure Information:
Title
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
Time Frame
5 Hours after initial dosing
Title
Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo
Time Frame
4 Hours after initial dosing
Secondary Outcome Measure Information:
Title
Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo
Time Frame
6.5 hours after initial dosing
Title
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo
Time Frame
5 hours after initial dosing
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 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
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
Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
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