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| ID | Type | Description | Link |
|---|---|---|---|
| CV013-005 | Other Identifier | BMS |
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| Name | Class |
|---|---|
| Cardioxyl Pharmaceuticals, Inc | INDUSTRY |
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This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXL-1427 (BMS-986231) | Experimental | Experimental |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXL-1427 Ascending Dose | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs) | Up to 31 days | |
| Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs) | Up to 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state plasma concentration (Css) | Up to 4 days | |
| Area under the plasma concentration (AUC) vs. time curve | Up to 4 days | |
| Terminal elimination half-life (1/2) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Cardioxyl Pharmaceuticals | Cardioxyl Pharmaceuticals | Study Director |
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| Other |
|
| CXL-1427 Descending Dose | Drug |
|
|
| Up to 4 days |
| Total body clearance (CL) | Up to 4 days |
| Steady-state volume of distributions (Vss) | Up to 4 days |
| Time to Css | Up to 4 days |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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