Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Specified dose on specified days |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-T) | Part 2 | Up to 22 days |
| AUC(INF) | Part 2 | Up to 22 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami | Miami | Florida | 33126 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| D012460 | Sulfasalazine |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Leucovorin |
| Drug |
Specified dose on specified days |
|
| BMS-986371 | Drug | Specified dose on specified days |
|
|
| Sulfasalazine | Drug | Specified dose on specified 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |