Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT06568458
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2024-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax)', 'timeFrame': 'Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)'}, {'measure': 'Area under the plasma concentration-time curve within a dosing interval AUC(TAU)', 'timeFrame': 'Day 4, 17 and 21 of Part 1'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)', 'timeFrame': 'Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)', 'timeFrame': 'Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with non-serious AEs (Adverse events)', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Number of participants with Serious AEs', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Number of participants with Physical examination abnormalities', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Number of participants with 12-lead electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 28 Days post discontinuation of dosing'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)'}, {'measure': 'Apparent terminal phase half-life (T-HALF)', 'timeFrame': 'Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)'}, {'measure': 'Apparent volume of distribution of terminal phase (Vz/F)', 'timeFrame': 'Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)'}]}, '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.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be healthy males and females (INOCBP)\n* Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.\n* Participant must have Body weight ≥ 50 kg\n\nExclusion Criteria:\n\n* Participant must not have current or recent GI disease\n* Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.\n* Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06568458', 'briefTitle': 'A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, 3-Part, Open-label Study to Assess the Pharmacokinetic Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 Tablet Formulations, and the Food Effect on the Pharmacokinetics of BMS-986278 When Orally Administered as a Phase 3 Tablet Formulation in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM027-1026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I: Period A', 'interventionNames': ['Drug: Nintedanib']}, {'type': 'EXPERIMENTAL', 'label': 'Part I: Period B', 'interventionNames': ['Drug: BMS 986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part I: Period C', 'interventionNames': ['Drug: Nintedanib', 'Drug: BMS 986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part II: Period 1', 'interventionNames': ['Drug: BMS 986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part II: Period 2', 'interventionNames': ['Drug: BMS 986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part II: Period 3', 'interventionNames': ['Drug: BMS 986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part III: Period 1', 'interventionNames': ['Drug: BMS 986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part III: Period 2', 'interventionNames': ['Drug: BMS 986278']}], 'interventions': [{'name': 'Nintedanib', 'type': 'DRUG', 'description': 'Specified Dose on specified days', 'armGroupLabels': ['Part I: Period A', 'Part I: Period C']}, {'name': 'BMS 986278', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part I: Period B', 'Part I: Period C', 'Part II: Period 1', 'Part II: Period 2', 'Part II: Period 3', 'Part III: Period 1', 'Part III: Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}