A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Leucovorin; Drug: Sulfasalazine; Drug: Methotrexate; Drug: BMS-986371

Study type: Interventional

Funder types: Industry

Identifiers

NCT05445440

IM046-003

Details and patient eligibility

About

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.

Full description

This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Part 1

Experimental group

Treatment:

Drug: BMS-986371

Drug: Leucovorin

Drug: Methotrexate

Part 2

Experimental group

Treatment:

Drug: BMS-986371

Drug: Leucovorin

Drug: Methotrexate

Drug: Sulfasalazine