Healthy Participants
Conditions
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.
Interventions
DRUGMethotrexate
Specified dose on specified days
DRUGLeucovorin
Specified dose on specified days
DRUGBMS-986371
Specified dose on specified days
DRUGSulfasalazine
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-T) | 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 |
| AUC(INF) | Up to 22 days | Part 2 |
| Cmax | Up to 22 days | Part 2 |
Countries
United States
Outcome results
None listed