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The study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T) of BMS-986177
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986177 and Itraconazole | Experimental | Single dose BMS-986177 on day 1 followed by Itraconazole and BMS-986177 on specified days |
|
| BMS-986177 and Diltiazem | Experimental | Single dose BMS-986177 on day 1 followed by Diltiazem ER and BMS-986177 on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug |
| ||
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) of BMS-986177 | Days 1-12 | |
| Maximum observed concentration (Cmax) | Days 1-12 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Days 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death | Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last scheduled visit occurs at a later time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35641780 | Derived | Perera V, Wang Z, Lubin S, Christopher LJ, Chen W, Xu S, Seiffert D, DeSouza M, Murthy B. Effects of Itraconazole and Diltiazem on the Pharmacokinetics and Pharmacodynamics of Milvexian, A Factor XIa Inhibitor. Cardiol Ther. 2022 Sep;11(3):407-419. doi: 10.1007/s40119-022-00266-6. Epub 2022 May 31. |
| Label | URL |
|---|---|
| Description 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 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Diltiazem ER | Drug |
|
| D010879 |
| Piperazines |