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The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Renal Function | Experimental |
| |
| Mild Renal Impairment | Experimental |
| |
| Moderate Renal Impairment | Experimental |
| |
| Severe Renal Impairment | Experimental |
| |
| End-Stage Renal Disease (ESRD) | Experimental | ESRD participants and are on chronic hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986224 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986224 | Up to 11 days | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 | Up to 11 days | |
| Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224 | Up to 11 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 | Up to 11 days | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986224 | Up to 11 days | |
| Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration | Up to 11 days | |
| Fraction of unbound drug in plasma (fu) of BMS-986224 | Up to 11 days | |
| Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration | Up to 11 days | |
| Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration | Up to 11 days | |
| Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | Up to 41 days | |
| Maximum observed plasma concentration (Cmax) of metabolite | Up to 11 days |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could 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 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Part 1 only |
| 7 days |
| Fraction of dose excreted in urine (Fe%) of BMS-986224 | Part 1 only | 7 days |
| Renal clearance of BMS-986224 derived from urine concentration | Part 1 only | 7 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite | Up to 11 days |
| Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite | Up to 11 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite | Up to 11 days |
| Time of maximum observed plasma concentration (Tmax) of metabolite | Up to 11 days |
| Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration | Up to 11 days |
| Metabolite-to-parent (MR) ratio for cMax | Up to 11 days |
| Metabolite-to-parent (MR) ratio for AUC(0-T) | Up to 11 days |
| Metabolite-to-parent (MR) ratio for AUC(0-72) | Up to 11 days |
| Metabolite-to-parent (MR) ratio for AUC(INF) | Up to 11 days |
| Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests | Up to 11 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| Prism Research | Saint Paul | Minnesota | 55114 | United States |
| FDA Safety Alerts and Recalls | View source |