A Phase 1, Two-part, Open-label, Drug-drug Interaction Study in Healthy Male Adult Participants to Evaluate the Effects of BMS-986371 on the Pharmacokinetics of Methotrexate in the Presence and Absence of Sulfasalazine

IM046-003

The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

2022-09-06

2022-11-17

2022-11-23

Completed

Early phase I

30

Inclusion Criteria: * Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol * Body mass index of 18 to 32 kg/m\^2, inclusive Exclusion Criteria: * Any significant acute or chronic medical illness * Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug * Any other medical, psychiatric and/or social reason as determined by the Investigator Other protocol-defined inclusion/exclusion criteria apply

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-02-08