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Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental | Methotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days |
|
| Cytochrome P450 and Transporter Substrates | Experimental | Caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986195 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Measured by plasma concentrations | Up to 26 days |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Measured by plasma concentrations | Up to 26 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Measured by plasma concentrations | Up to 26 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Measured by investigator assessment | Up to 28 days |
| Number of participants with serious adverse events | Measured by investigator assessment |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| Methotrexate | Drug | Specified dose on specified days |
|
| Leucovorin | Drug | Specified dose on specified days |
|
| Caffeine | Drug | Specified dose on specified days |
|
| Montelukast | Drug | Specified dose on specified days |
|
| Flurbiprofen | Drug | Specified dose on specified days |
|
| Omeprazole | Drug | Specified dose on specified days |
|
| Midazolam | Drug | Specified dose on specified days |
|
| Digoxin | Drug | Specified dose on specified days |
|
| Pravastatin | Drug | Specified dose on specified days |
|
| Up to 45 days |
| Number of participants with adverse events leading to discontinuation | Measured by investigator assessment | Up to 28 days |
| Number of participants with clinical laboratory test abnormalities | Up to 28 days |
| Number of participants with vital sign measurement abnormalities | Up to 28 days |
| Number of participants with electrocardiogram abnormalities | Up to 28 days |
| Number of participants with physical examination abnormalities | Up to 28 days |
| Number of participants with marked abnormalities in clinical laboratory test results | Up to 28 days |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000710709 | branebrutinib |
| D008727 | Methotrexate |
| D002955 | Leucovorin |
| D002110 | Caffeine |
| C093875 | montelukast |
| D005480 | Flurbiprofen |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| D004077 | Digoxin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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