Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 10:19 PM
Study NCT ID:
NCT05932303
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D015248', 'term': 'Gemfibrozil'}, {'id': 'D002220', 'term': 'Carbamazepine'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 33 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])', 'timeFrame': 'Up to 33 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])', 'timeFrame': 'Up to 33 days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 33 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 33 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 33 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 33 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 33 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986278', 'Itraconazole', 'Gemfibrozil', 'Carbamazepine', 'Idiopathic pulmonary fibrosis', 'Drug interaction'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\\^2) through 32.0 kg/m\\^2, inclusive.\n\nBMI = weight (kg)/(height \\[m\\])2.\n\n* Body weight ≥ 50 kg for males and ≥ 45 kg for females.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness.\n* Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.\n* Any major surgery within 4 weeks of study intervention administration.\n\nOther protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05932303', 'briefTitle': 'A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM027-1007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986278, followed by itraconazole', 'interventionNames': ['Drug: BMS-986278', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986278, followed by gemfibrozil', 'interventionNames': ['Drug: BMS-986278', 'Drug: Gemfibrozil']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986278, followed by carbamazepine', 'interventionNames': ['Drug: BMS-986278', 'Drug: Carbamazepine']}], 'interventions': [{'name': 'BMS-986278', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986278, followed by carbamazepine', 'BMS-986278, followed by gemfibrozil', 'BMS-986278, followed by itraconazole']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986278, followed by itraconazole']}, {'name': 'Gemfibrozil', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986278, followed by gemfibrozil']}, {'name': 'Carbamazepine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986278, followed by carbamazepine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1P 0A2', 'city': 'Québec', 'state': 'CA', 'country': 'Canada', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}