Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06746402
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2024-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double-blind study, with an open-label positive control in Part B.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part A, a parallel model, will be followed by Part B, a 4-way crossover model.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with non-serious Adverse Events (AEs)', 'timeFrame': 'Until 28 days post last treatment dose', 'description': 'Part A'}, {'measure': 'Number of participants with Serious AEs (SAEs)', 'timeFrame': 'Until 28 days post last treatment dose', 'description': 'Part A'}, {'measure': 'Number of participants with AEs leading to study intervention discontinuation', 'timeFrame': 'Until 28 days post last treatment dose', 'description': 'Part A'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to Day 18', 'description': 'Part A'}, {'measure': 'Number of participants with clinical laboratory assessment abnormalities', 'timeFrame': 'Up to Day 18', 'description': 'Part A'}, {'measure': 'Number of participants with 12-lead electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to Day 18', 'description': 'Part A'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 18', 'description': 'Part A'}, {'measure': "Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)", 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Placebo-corrected change from baseline QTcF (ΔΔQTcF)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part A and Part B'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part A and Part B'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part A and Part B'}, {'measure': 'Terminal half-life (T-HALF)', 'timeFrame': 'Up to Day 18', 'description': 'Part A'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to Day 18', 'description': 'Part A'}, {'measure': 'Change from baseline heart rate (HR) (∆HR)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Change from baseline PR interval (∆PR)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Change from baseline QRS interval (∆QRS)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Placebo-corrected change from baseline HR (ΔΔHR)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Placebo-corrected Change from baseline PR interval (ΔΔPR)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Placebo-corrected change from baseline QRS interval (ΔΔQRS)', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with categorical outliers for QTcF', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with categorical outliers for HR', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with categorical outliers for PR interval', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with categorical outliers for QRS interval', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with treatment-emergent changes of ECG morphology', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'ΔQTcF for moxifloxacin', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'ΔΔQTcF for moxifloxacin', 'timeFrame': 'Up to Day 13 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with non-serious AEs', 'timeFrame': 'Until 28 days post last treatment dose', 'description': 'Part B'}, {'measure': 'Number of participants with SAEs', 'timeFrame': 'Until 28 days post last treatment dose', 'description': 'Part B'}, {'measure': 'Number of participants with AEs leading to study intervention discontinuation', 'timeFrame': 'Until 28 days post last treatment dose', 'description': 'Part B'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to Day 18 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with clinical laboratory assessment abnormalities', 'timeFrame': 'Up to Day 17 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with 12-lead ECG abnormalitie', 'timeFrame': 'Up to Day 17 of Period 4 (Each period is 17 days)', 'description': 'Part B'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 18 of Period 4 (Each period is 17 days)', 'description': 'Part B'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, '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 this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female individuals not of childbearing potential (INOCBP) and males.\n* Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.\n* Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness as determined by the investigator.\n* History of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias.\n* Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study.\n* Other protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06746402', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization (Part B) in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM027-1012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'interventionNames': ['Drug: BMS-986278', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B1/B2 Treatment A', 'interventionNames': ['Drug: BMS-986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part B1/B2 Treatment B', 'interventionNames': ['Drug: BMS-986278', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B1/B2 Treatment C', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B1/B2 Treatment D', 'interventionNames': ['Drug: Placebo', 'Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B3 Treatment A', 'interventionNames': ['Drug: BMS-986278']}, {'type': 'EXPERIMENTAL', 'label': 'Part B3 Treatment B', 'interventionNames': ['Drug: BMS-986278', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B3 Treatment C', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B3 Treatment D', 'interventionNames': ['Drug: Placebo', 'Drug: Moxifloxacin']}], 'interventions': [{'name': 'BMS-986278', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A', 'Part B1/B2 Treatment A', 'Part B1/B2 Treatment B', 'Part B3 Treatment A', 'Part B3 Treatment B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A', 'Part B1/B2 Treatment B', 'Part B1/B2 Treatment C', 'Part B1/B2 Treatment D', 'Part B3 Treatment B', 'Part B3 Treatment C', 'Part B3 Treatment D']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part B1/B2 Treatment D', 'Part B3 Treatment D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], '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.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See Plan Description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}