Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT00979368
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2009-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of BMS-816336 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621809', 'term': 'BMS-816336'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2009-09-17', 'studyFirstSubmitQcDate': '2009-09-17', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exposure to the investigational drug will be measured to assess safety and tolerability', 'timeFrame': 'Within 72 hours following dosing'}], 'secondaryOutcomes': [{'measure': 'To assess the single dose Pharmacokinetics of BMS-816336', 'timeFrame': 'During 72 hours following dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent', 'Dyslipidemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subjects\n* BMI of 18 to 32 kg/m²\n* Men only, ages 18-55 years\n\nExclusion Criteria:\n\n* Sexually active men not using effective birth control if their partners are WOCBP\n* Any significant acute or chronic medical illness\n* Family history of Gilbert's disease\n* History of Pancreatitis\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations\n* QTc interval \\> 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)\n* Second- or third-degree A-V block or clinically relevant ECG abnormalities\n* History of allergy to 11-β-HSD-1 inhibitors or related compounds\n* Prior exposure to BMS-816336\n* Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study\n* Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration\n* Use of any glucocorticoid topical creams within 4 weeks of study drug administration\n* Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment"}, 'identificationModule': {'nctId': 'NCT00979368', 'briefTitle': 'Safety Study of BMS-816336 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'MB124-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-816336 or placebo (Panel 1)', 'interventionNames': ['Drug: BMS-816336', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-816336 or placebo (Panel 2)', 'interventionNames': ['Drug: BMS-816336', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-816336 or placebo (Panel 3)', 'interventionNames': ['Drug: BMS-816336', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-816336 or placebo (Panel 4)', 'interventionNames': ['Drug: BMS-816336', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-816336 or placebo (Panel 5)', 'interventionNames': ['Drug: BMS-816336', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-816336', 'type': 'DRUG', 'description': 'Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days', 'armGroupLabels': ['BMS-816336 or placebo (Panel 1)']}, {'name': 'BMS-816336', 'type': 'DRUG', 'description': 'Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days', 'armGroupLabels': ['BMS-816336 or placebo (Panel 2)']}, {'name': 'BMS-816336', 'type': 'DRUG', 'description': 'Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days', 'armGroupLabels': ['BMS-816336 or placebo (Panel 3)']}, {'name': 'BMS-816336', 'type': 'DRUG', 'description': 'Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days', 'armGroupLabels': ['BMS-816336 or placebo (Panel 4)']}, {'name': 'BMS-816336', 'type': 'DRUG', 'description': 'Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days', 'armGroupLabels': ['BMS-816336 or placebo (Panel 5)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Suspension, Oral, 0 mg, Once on Day 1 only, 4 days', 'armGroupLabels': ['BMS-816336 or placebo (Panel 1)', 'BMS-816336 or placebo (Panel 2)', 'BMS-816336 or placebo (Panel 3)', 'BMS-816336 or placebo (Panel 4)', 'BMS-816336 or placebo (Panel 5)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}