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A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hepatic Subjects | Experimental | Subjects are given a single dose of BMS-986177 |
|
| Moderate Hepatic Subjects | Experimental | Subjects are given a single dose of BMS-986177 |
|
| Healthy Match Subjects | Experimental | Subjects are given a single dose of BMS-986177 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug | Single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986177 | Up to 5 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177 | Up to 5 days | |
| Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177 | Up to 5 days | |
| Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177 | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation | Screening until 30 days after discontinuation of dosing or subject's participation | |
| Number of participants with clinical laboratory abnormalities | Screening until 30 days after discontinuation of dosing or subject's participation |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may 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 | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35262846 | Derived | Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Chen W, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Mild or Moderate Hepatic Impairment Compared with Healthy Participants. Clin Pharmacokinet. 2022 Jun;61(6):857-867. doi: 10.1007/s40262-022-01110-9. Epub 2022 Mar 9. |
| Label | URL |
|---|---|
| Investigator Inquiry Form | 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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| Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG) | Screening until 30 days after discontinuation of dosing or subject's participation |
| Number of participants with vital sign abnormalities | Screening until 30 days after discontinuation of dosing or subject's participation |
| Orlando |
| Florida |
| 32809 |
| United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Education Resource | View source |