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Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Normal Renal Function |
|
| Group B | Experimental | Moderate Renal Impairment |
|
| Group C | Experimental | Severe Renal Impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug | Oral Suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Measured by plasma concentration | Up to 5 days |
| AUC from time zero to time of last quantifiable concentration (AUC (0-T)) | Summary measures of PK parameters | Up to 5 days |
| AUC from time zero extrapolated to infinite time (AUC (INF)) | Summary measures of PK parameters | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 5 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 and 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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Of Miami Inc. | Miami | Florida | 33014 | United States | ||
| Clinical Pharmacology of Miami LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35906349 | Derived | Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment. Clin Pharmacokinet. 2022 Oct;61(10):1405-1416. doi: 10.1007/s40262-022-01150-1. Epub 2022 Jul 30. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Up to 30 days |
| Change from baseline in electrocardiogram findings | Measured by investigator assessment | Up to 5 days |
| Change from baseline in physical examination findings | Measured by investigator assessment | Up to 5 days |
| Change from baseline in clinical laboratory test findings | Measured by investigator assessment | Up to 5 days |
| Miami |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| 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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