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This study is to evaluate the effect of dilitazem on the single-dose PK of BMS-986141 with parameters like Cmax, AUC(INF), and AUC(0-T).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986141 and Dilitazem | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986141 | Drug | Single dose BMS-986141 and Multiple doses of Dilitazem |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Days 1-21 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Days 1-21 | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) | Days 1-21 |
| 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] |
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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 |
|---|---|---|---|---|---|---|
| PPD Development | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000729678 | BMS-986141 |
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| Dilitazem |
| Drug |
Single dose BMS-986141 and Multiple doses of Dilitazem |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |