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The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BMS-986278 suspension, fasted | Experimental |
| |
| Treatment B: BMS-986278 tablet, fasted | Experimental |
| |
| Treatment C: BMS-986278 tablet, fed | Experimental |
| |
| Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 Tablet | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of BMS-986278 | Up to 5 days | |
| Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278 | Up to 5 days | |
| Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 29 days | |
| Incidence of Serious Adverse (SAE's) | Up to 57 days | |
| Incidence of AEs leading to discontinuation |
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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 (LPRA) - Salt Lake | Salt Lake City | Utah | 84124 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Esomeprazole | Drug | Specified dose on specified days |
|
|
| BMS-986278 suspension | Drug | Specified dose on specified days |
|
| Up to 29 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 48 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 48 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 48 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 48 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters | Up to 48 days |
| Incidence of clinically significant changes in physical examination findings | Up to 48 days |
| Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests | Up to 48 days |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 48 days |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 48 days |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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