Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT03035734
Status:
WITHDRAWN
Last Update Posted:
2018-03-23
First Post:
2016-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx', 'label': 'Investigator inquiry form'}]}, 'descriptionModule': {'briefSummary': 'Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments\n* Body mass index 18.0 kg/m2 to 32.0 kg/m2\n* females must be of non-childbearing potential\n\nExclusion Criteria:\n\n* known bleeding or coagulation disorders\n* acute or chronic medical illness\n* history of nausea or chronic diarrhea that lasts over 4 weeks\n* history of periodontal disease or gingivitis which required treatment\n* other exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03035734', 'briefTitle': 'Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants', 'orgStudyIdInfo': {'id': 'CV006-023'}, 'secondaryIdInfos': [{'id': '2016-001031-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Single oral dose BMS-986141 Form A tablet under fasting conditions', 'interventionNames': ['Drug: BMS-986141 Form A Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions', 'interventionNames': ['Drug: BMS-986141 Form B tablet (low dose)']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions', 'interventionNames': ['Drug: BMS-986141 Form B tablet (high dose)']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions', 'interventionNames': ['Drug: BMS-986141 Form B tablet (high dose)']}], 'interventions': [{'name': 'BMS-986141 Form A Tablet', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['A']}, {'name': 'BMS-986141 Form B tablet (low dose)', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['B']}, {'name': 'BMS-986141 Form B tablet (high dose)', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['C', 'D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}