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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Leucovorin
* Drug: BMS-986371
* Drug: Sulfasalazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: Methotrexate<br>* Specified dose on specified days<br>Drug: Leucovorin<br>* Specified dose on specified days<br>Drug: BMS-986371<br>* Specified dose on specified days<br>* Other names: CC-99677;|
| Experimental: Part 2<br> | Drug: Methotrexate<br>* Specified dose on specified days<br>Drug: Leucovorin<br>* Specified dose on specified days<br>Drug: BMS-986371<br>* Specified dose on specified days<br>* Other names: CC-99677;Drug: Sulfasalazine<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) | Part 1 | Up to 22 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Part 1 | Up to 22 days | 
| Maximum observed plasma concentration (Cmax) | Part 1 | Up to 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-T) | Part 2 | Up to 22 days | 
| AUC(INF) | Part 2 | Up to 22 days | 
| Cmax | Part 2 | Up to 22 days | 
| Number of participants with adverse events (AEs) | Parts 1 and 2 | Up to 30 days post participant's last study treatment |