A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05445440
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 BMS-986371 - Part 1 Methotrexate - Part 1 BMS-986371 - Part 1 Leucovorin - Part 2 Methotrexate - Part 2 Leucovorin - Part 2 Sulfasalazine -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 22 days Part 1
Maximum observed plasma concentration (Cmax) Up to 22 days Part 1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) Up to 22 days Part 1
- Secondary Outcome Measures
Name Time Method AUC(0-T) Up to 22 days Part 2
AUC(INF) Up to 22 days Part 2
Cmax Up to 22 days Part 2
Number of participants with adverse events (AEs) Up to 30 days post participant's last study treatment Parts 1 and 2
Trial Locations
- Locations (1)
Quotient Sciences Miami
🇺🇸Miami, Florida, United States