Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05615012
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2022-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D002955', 'term': 'Leucovorin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 21 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])', 'timeFrame': 'Up to 21 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])', 'timeFrame': 'Up to 21 days'}], 'secondaryOutcomes': [{'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 21 days'}, {'measure': 'Apparent terminal phase half-life (T-HALF)', 'timeFrame': 'Up to 21 days'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to 21 days'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 51 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986322', 'Rosuvastatin', 'Metformin', 'Methotrexate'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.\n* Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)\\^2 to 30.0 kg/m\\^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening.\n* A female participant is eligible to participate if she is a woman not of childbearing potential.\n* Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention.\n* For Parts 1 and 2 participants must be 18 to 60 years of age.\n* For Part 3 participants must be 18 to 50 years of age.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness.\n* Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration.\n* History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre \\[mL\\] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).\n* Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status.\n* Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB.\n\nOther protocol-defined inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT05615012', 'briefTitle': 'A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State BMS-986322 on the Pharmacokinetics of Rosuvastatin (Part 1), the Pharmacokinetics and Pharmacodynamics of Metformin (Part 2) and the Pharmacokinetics of Methotrexate (Part 3) in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM032-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Rosuvastatin + BMS-986322', 'interventionNames': ['Drug: BMS-986322', 'Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Metformin + BMS-986322 + Glucose', 'interventionNames': ['Drug: BMS-986322', 'Drug: Metformin', 'Dietary Supplement: Glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Methotrexate + BMS-986322 + Leucovorin', 'interventionNames': ['Drug: BMS-986322', 'Drug: Methotrexate', 'Drug: Leucovorin']}], 'interventions': [{'name': 'BMS-986322', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1: Rosuvastatin + BMS-986322', 'Part 2: Metformin + BMS-986322 + Glucose', 'Part 3: Methotrexate + BMS-986322 + Leucovorin']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1: Rosuvastatin + BMS-986322']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 2: Metformin + BMS-986322 + Glucose']}, {'name': 'Glucose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 2: Metformin + BMS-986322 + Glucose']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 3: Methotrexate + BMS-986322 + Leucovorin']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 3: Methotrexate + BMS-986322 + Leucovorin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], '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-and-research/disclosurecommitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}