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The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail Probe Substrates + BMS-986419 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986419 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 25 | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 25 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 25 | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 25 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Lenexa | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Caffeine |
| Drug |
Specified dose on specified days |
|
| Bupropion | 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 |
|
| Fexofenadine | Drug | Specified dose on specified days |
|
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) |
| Up to Day 25 |
| Number of participants with Adverse Events (AEs) | Up to 28 days after last dose |
| Number of participants with Serious Adverse Events (SAEs) | Up to 28 days after last dose |
| Number of participants with AEs leading to discontinuation | Up to 28 days after last dose |
| Number of participants with vital sign abnormalities | Up to Day 25 |
| Number of participants with 12-lead ECG assessment abnormalities | Up to Day 25 |
| Number of participants with physical examination abnormalities | Up to Day 25 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 25 |
| Number of participants with clinical laboratory abnormalities | Up to Day 25 |
| ID | Term |
|---|---|
| D002110 | Caffeine |
| D016642 | Bupropion |
| D005480 | Flurbiprofen |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| C093230 | fexofenadine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| 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 |
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