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Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Receive 200 mg BMS-986177 Form A without food |
|
| Treatment B | Experimental | Receive 200 mg BMS-986177 Form B without food |
|
| Treatment C | Experimental | Receive 200 mg BMS-986177 Form B with food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug | Form A |
| |
| BMS-986177 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Measured by plasma concentration | Up to 3 days |
| AUC from time zero to time of last quantifiable concentration (AUC(0-T)) | Measured by plasma concentration | Up to 3 days |
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Measured by plasma concentration | Up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 12 days |
| Incidence of Serious Adverse Events (SAEs) | Safety and tolerability as measured by incidence of SAEs |
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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 | Briston-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000720754 | milvexian |
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| Drug |
Form B |
|
| Up to 30 days |
| Number of participants with electrocardiogram abnormalities | Up to 12 days |
| Number of participants with physical examination abnormalities | Up to 12 days |
| Number of participants with clinical laboratory abnormalities | Up to 12 days |