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The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be assessed, as will the effect of BMS-986177 on the PK of aspirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Active Comparator | 325 mg tablet, once daily for 5 days (Day -5 to -1) |
|
| BMS-986177 plus aspirin | Experimental | 200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7) |
|
| Placebo plus aspirin | Placebo Comparator | 200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 1 x 325 mg tablet of aspirin administered once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily) | Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment | Up to 10 days |
| Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily) | Measured by electrocardiogram (ECG) | Up to 10 days |
| Number of participants with vital sign abnormalities. | Up to 10 days | |
| Number of participants with physical examination abnormalities. | Up to 10 days | |
| Number of participants with clinical laboratory abnormalities. | Up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/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 Austin Clinic | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C000720754 | milvexian |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| BMS-986177 | Drug | 200 mg of BMS-986177 administered twice daily |
|
| Placebo | Drug | 200 mg of Placebo administered twice daily |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |