Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02932969
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations', 'timeFrame': '11 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Decompensation, Acute']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/pages/home.aspx', 'label': 'BMS Clinical Trial Education Resource'}, {'url': 'http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ancestry\n\n * First generation Japanese\n * Non-Asian with grandparents and parents of non-Asian descent\n* Body weight greater than or equal to 45kg and less than or equal to 110kg\n* Women of childbearing potential have specific birthcontrol methods\n* Males sexually active with women of childbearing potential have specific birthcontrol methods\n\nExclusion Criteria:\n\n* History of chronic illness\n* Chronic headaches\n* Recurrent dizziness\n* Personal or family history of heart disease\n* Personal history of bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT02932969', 'briefTitle': 'Study With Healthy Japanese and Non-Asian Participants With BMS-986231', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants', 'orgStudyIdInfo': {'id': 'CV013-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel 1 Arm', 'description': 'BMS-986231 and BMS-986231 Placebo intravenously', 'interventionNames': ['Drug: BMS-986231', 'Drug: BMS-986231 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2 Arm', 'description': 'BMS-986231 and BMS-986231 Placebo intravenously', 'interventionNames': ['Drug: BMS-986231', 'Drug: BMS-986231 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 3 Arm', 'description': 'BMS-986231 and BMS-986231 Placebo intravenously', 'interventionNames': ['Drug: BMS-986231', 'Drug: BMS-986231 Placebo']}], 'interventions': [{'name': 'BMS-986231', 'type': 'DRUG', 'armGroupLabels': ['Panel 1 Arm', 'Panel 2 Arm', 'Panel 3 Arm']}, {'name': 'BMS-986231 Placebo', 'type': 'DRUG', 'armGroupLabels': ['Panel 1 Arm', 'Panel 2 Arm', 'Panel 3 Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials, Llc', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}