Overview

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

Status:
Not yet recruiting
Trial end date:
2023-01-26
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Leucovorin
Methotrexate
Sulfasalazine
Criteria
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