Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-25 @ 5:11 AM
Study NCT ID:
NCT03634969
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986224', 'timeFrame': 'Up to 11 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224', 'timeFrame': 'Up to 11 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224', 'timeFrame': 'Up to 11 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224', 'timeFrame': 'Up to 11 days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of BMS-986224', 'timeFrame': 'Up to 11 days'}, {'measure': 'Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration', 'timeFrame': 'Up to 11 days'}, {'measure': 'Fraction of unbound drug in plasma (fu) of BMS-986224', 'timeFrame': 'Up to 11 days'}, {'measure': 'Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration', 'timeFrame': 'Up to 11 days'}, {'measure': 'Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration', 'timeFrame': 'Up to 11 days'}, {'measure': 'Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224', 'timeFrame': '7 days', 'description': 'Part 1 only'}, {'measure': 'Fraction of dose excreted in urine (Fe%) of BMS-986224', 'timeFrame': '7 days', 'description': 'Part 1 only'}, {'measure': 'Renal clearance of BMS-986224 derived from urine concentration', 'timeFrame': '7 days', 'description': 'Part 1 only'}], 'secondaryOutcomes': [{'measure': 'Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation', 'timeFrame': 'Up to 41 days'}, {'measure': 'Maximum observed plasma concentration (Cmax) of metabolite', 'timeFrame': 'Up to 11 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite', 'timeFrame': 'Up to 11 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite', 'timeFrame': 'Up to 11 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite', 'timeFrame': 'Up to 11 days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of metabolite', 'timeFrame': 'Up to 11 days'}, {'measure': 'Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration', 'timeFrame': 'Up to 11 days'}, {'measure': 'Metabolite-to-parent (MR) ratio for cMax', 'timeFrame': 'Up to 11 days'}, {'measure': 'Metabolite-to-parent (MR) ratio for AUC(0-T)', 'timeFrame': 'Up to 11 days'}, {'measure': 'Metabolite-to-parent (MR) ratio for AUC(0-72)', 'timeFrame': 'Up to 11 days'}, {'measure': 'Metabolite-to-parent (MR) ratio for AUC(INF)', 'timeFrame': 'Up to 11 days'}, {'measure': 'Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests', 'timeFrame': 'Up to 11 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Failure', 'Myocardial Failure']}, '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': 'The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 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* BMI ≥18 and ≤ 35kg/m2\n* Systolic blood pressure \\>100 mmHg\n\nExclusion Criteria:\n\n* Women of childbearing potential or women who are currently pregnant\n* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer\n* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03634969', 'briefTitle': 'An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function', 'orgStudyIdInfo': {'id': 'CV016-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Renal Function', 'interventionNames': ['Drug: BMS-986224']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Renal Impairment', 'interventionNames': ['Drug: BMS-986224']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Renal Impairment', 'interventionNames': ['Drug: BMS-986224']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Renal Impairment', 'interventionNames': ['Drug: BMS-986224']}, {'type': 'EXPERIMENTAL', 'label': 'End-Stage Renal Disease (ESRD)', 'description': 'ESRD participants and are on chronic hemodialysis', 'interventionNames': ['Drug: BMS-986224']}], 'interventions': [{'name': 'BMS-986224', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['End-Stage Renal Disease (ESRD)', 'Mild Renal Impairment', 'Moderate Renal Impairment', 'Normal Renal Function', 'Severe Renal Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}