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The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAD | Experimental | SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo. |
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| Part B: MAD | Experimental | MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo. |
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| Part C: FE/Formul. | Experimental | FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986196 | Drug | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 24 days | |
| Severity of AEs | Up to 24 days | |
| Causality of AEs | Up to 24 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 59 days | |
| Severity of SAEs | Up to 59 days | |
| Causality of SAEs | Up to 59 days | |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 24 days | |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 24 days | |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 24 days | |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 24 days | |
| Incidence of clinically significant changes in weight | Up to 24 days |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0002 | 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 |
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| Placebo | Other | Specified dose on specified days |
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| Incidence of clinically significant changes in physical examination | Up to 24 days |
| Incidence of clinically significant changes in ECG parameters: QT interval | Up to 24 days |
| Incidence of clinically significant changes in ECG parameters: HR | Up to 24 days |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 24 days |
| Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 24 days |
| Incidence of clinically significant changes in clinical laboratory values: Coagulation tests | Up to 24 days |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 24 days |