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The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment | Experimental | Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2 |
|
| Moderate renal impairment | Experimental | Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2 |
|
| Severe renal impairment | Experimental | Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis |
|
| Normal renal function | Experimental | Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986231 | Drug | Intravenous infusion administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) derived from plasma concentration | 11 days | |
| Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration | 11 days | |
| Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration | 11 days | |
| Clearance (CL) derived from plasma concentration | 11 days | |
| Renal clearance (CLR) derived from urine concentration | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AE) | Up to 31 days | |
| Number of serious adverse events (SAE) | Up to 31 days | |
| Terminal elimination half-life (t1/2) |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Prague | 170 00 | Czechia | |||
| Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II |
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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 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Up to 36 hours |
| Time of maximum observed plasma concentration (Tmax) | Up to 36 hours |
| AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt) | Up to 36 hours |
| Terminal elimination phase rate constant (λz) | Up to 36 hours |
| Volume of distribution during terminal phase (Vz) | Up to 36 hours |
| Fraction of administered drug excreted into urine (Fe) | Up to 36 hours |
| Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast) | Up to 36 hours |
| Grodzisk Mazowiecki |
| 05-825 |
| Poland |
| Specjalistyczne Centrum Medyczne Panacea Poznan | Krakow | 31-559 | Poland |
| FDA Safety Alerts and Recalls | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |