Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-27 @ 2:28 PM
Study NCT ID:
NCT00934466
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2009-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-23', 'studyFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo', 'timeFrame': '5 Hours after initial dosing'}, {'measure': 'Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo', 'timeFrame': '4 Hours after initial dosing'}], 'secondaryOutcomes': [{'measure': 'Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo', 'timeFrame': '6.5 hours after initial dosing'}, {'measure': 'Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo', 'timeFrame': '5 hours after initial dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is right-handed\n* Subject is in good health\n* Subject is a nonsmoker\n\nExclusion Criteria:\n\n* Subject works a night shift\n* Subject has a history of any illness that might make participation in the study unsafe or confound the study results\n* Subject has a history of head injury'}, 'identificationModule': {'nctId': 'NCT00934466', 'briefTitle': 'Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects', 'orgStudyIdInfo': {'id': '2637-008'}, 'secondaryIdInfos': [{'id': 'MK2637-008'}, {'id': '2009_608'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MK2637 120 mg', 'interventionNames': ['Drug: MK2637']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'MK2637 50 mg', 'interventionNames': ['Drug: Comparator: MK2637']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Dextromethorphan 220 mg', 'interventionNames': ['Drug: Comparator: Dextromethorphan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'Dextromethorphan 110 mg', 'interventionNames': ['Drug: Comparator: Dextromethorphan']}], 'interventions': [{'name': 'MK2637', 'type': 'DRUG', 'description': 'Single dose of 120 mg MK2637 capsules in one of five treatment periods.', 'armGroupLabels': ['1']}, {'name': 'Comparator: MK2637', 'type': 'DRUG', 'description': 'Single dose of 50 mg MK2637 capsules in one of five treatment periods.', 'armGroupLabels': ['2']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Single dose of placebo only in one of five treatment periods.', 'armGroupLabels': ['3']}, {'name': 'Comparator: Dextromethorphan', 'type': 'DRUG', 'description': 'Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.', 'armGroupLabels': ['4']}, {'name': 'Comparator: Dextromethorphan', 'type': 'DRUG', 'description': 'Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}