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An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End Stage Renal Disease Subjects | Experimental | Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the Number of subjects with Adverse events (AEs). | Day -1 - day 3 | |
| To assess the Change from baseline in Physical examination parameters. | Day -1 - day 3 | |
| To assess the change from baseline in Electrocardiogram (ECG) assessment. | Day -1 - day 3 | |
| To assess the change from baseline in clinical laboratory values. | Day -1 - day 3 | |
| To assess the change from baseline in vital signs assessment. | Day -1 - day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change from baseline in activated partial thromboplastin time (aPTT). | Day -1 - day 3 | |
| To assess the change from baseline in Factor XI clotting activity (FX1c ). | Day -1 - day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D051437 | Renal Insufficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000720754 | milvexian |
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