Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-06 @ 5:46 AM
Study NCT ID:
NCT04124003
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2019-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2019-10-09', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'up to Day 10'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)', 'timeFrame': 'up to Day 10'}, {'measure': 'Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)', 'timeFrame': 'up to Day 10'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Number of significant changes in lab assessments of blood serum', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Number of significant changes in lab assessments of blood', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Number of significant changes in lab assessments of urine', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Blood pressure', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Body temperature', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Respiratory rate', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Number of Participants with abnormal physical examination findings', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Heart rate', 'timeFrame': 'Approximately 50 days'}, {'measure': 'Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Approximately 50 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n* Women must not be of childbearing potential (WNOCBP)\n* Women and men must agree to follow instructions for methods of contraception\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.\n* Any major surgery within 4 weeks of study drug administration\n* Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration\n* Previous treatment with BMS-963272\n* Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1\n\nOther protocol-defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT04124003', 'briefTitle': 'A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants', 'orgStudyIdInfo': {'id': 'MB006-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rosuvastatin + BMS-963272', 'interventionNames': ['Drug: rosuvastatin', 'Drug: BMS-963272']}], 'interventions': [{'name': 'rosuvastatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['rosuvastatin + BMS-963272']}, {'name': 'BMS-963272', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['rosuvastatin + BMS-963272']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences - Salt Lake', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}