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The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1 Arm | Experimental | BMS-986231 and BMS-986231 Placebo intravenously |
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| Panel 2 Arm | Experimental | BMS-986231 and BMS-986231 Placebo intravenously |
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| Panel 3 Arm | Experimental | BMS-986231 and BMS-986231 Placebo intravenously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986231 | Drug |
| ||
| BMS-986231 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations | 11 days |
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Inclusion Criteria:
Ancestry
Body weight greater than or equal to 45kg and less than or equal to 110kg
Women of childbearing potential have specific birthcontrol methods
Males sexually active with women of childbearing potential have specific birthcontrol methods
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials, Llc | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
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