Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01017458
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2009-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550076', 'term': '3-fluoro-N-(3H-imidazo(4,5-b)pyridin-2-ylmethyl)-1,4a,6a-trimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1H-indeno(5,4-f)quinoline-7-carboxamide'}, {'id': 'C004648', 'term': 'testosterone enanthate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Clinical Adverse Events (CAE)', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with Serious CAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with drug-related CAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with serious drug-related CAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects that discontinued with CAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with Laboratory Adverse Events (LAE)', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with drug-related LAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with serious LAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects with serious drug-related LAEs', 'timeFrame': '12 weeks'}, {'measure': 'Number of subjects that discontinued with LAEs', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy Adults'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is in good general health\n* Subject agrees to avoid excess alcohol and strenuous physical activity during the study\n* Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study\n\nExclusion Criteria:\n\n* Subject has significant drug allergies\n* Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks\n* Subject is a regular user or past abuser of any illicit drug (including alcohol)\n* Subject drinks excessive amounts of caffeinated beverages\n* Subject has a history of cancer\n* Subject has a history of prostate or testicular surgery'}, 'identificationModule': {'nctId': 'NCT01017458', 'briefTitle': 'Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men', 'orgStudyIdInfo': {'id': '0773-004'}, 'secondaryIdInfos': [{'id': '2009_693'}, {'id': 'MK-0773-004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MK0773 + placebo injection', 'interventionNames': ['Drug: MK0773', 'Drug: Comparator: placebo injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'placebo to MK0773 + testosterone injection', 'interventionNames': ['Drug: Comparator: testosterone enanthate', 'Drug: Comparator: placebo oral tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'placebo to MK0773 + placebo injection', 'interventionNames': ['Drug: Comparator: placebo oral tablet', 'Drug: Comparator: placebo injection']}], 'interventions': [{'name': 'MK0773', 'type': 'DRUG', 'description': 'Three 25mg oral tablets MK0773 bid, for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'Comparator: testosterone enanthate', 'type': 'DRUG', 'otherNames': ['Delatestryl'], 'description': 'intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'Comparator: placebo oral tablet', 'type': 'DRUG', 'description': 'placebo oral tablet bid, for 12 weeks', 'armGroupLabels': ['2', '3']}, {'name': 'Comparator: placebo injection', 'type': 'DRUG', 'description': 'placebo intramuscular injection q14d, for 12 weeks', 'armGroupLabels': ['1', '3']}]}, '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'}}}}