A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1
|
Drug: Methotrexate
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Drug: BMS-986371
Specified dose on specified days
Other Names:
|
Experimental: Part 2
|
Drug: Methotrexate
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Drug: BMS-986371
Specified dose on specified days
Other Names:
Drug: Sulfasalazine
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM046-003