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A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
Recruitment temporarily on hold due to COVID-19
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Normal Renal Function | Experimental |
| |
| Arm B: Mild Renal Impairment | Experimental |
| |
| Arm C: Moderate Renal Impairment | Experimental |
| |
| Arm D: Severe Renal Impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986259 | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum | Day 1 and Day 8 | |
| Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum | Day 1 and Day 8 | |
| Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU) | Day 1 and Day 8 | |
| Concentration of BMS-986259 in blood serum at 24 hours (C24) | Day 1 and Day 8 | |
| Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T) | Day 8 | |
| Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax) | Day 8 | |
| Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU]) | Day 8 | |
| Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24) | Day 8 | |
| Terminal elimination half-life of BMS-986259 (T-HALF) | Day 8 | |
| Apparent total clearance of BMS-986259 at steady-state (CLss/F) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Non serious Adverse Events (AEs) | Up to 4 months | |
| Incidence of Serious Adverse Events (SAEs) | Up to 4 months | |
| Incidence of AEs leading to discontinuation |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria 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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| Day 8 |
| Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F) | Day 8 |
| Up to 4 months |
| Number of clinically significant changes in vital signs | Up to 4 months |
| Number in clinically significant changes in Electrocardiogram (ECG) | Up to 4 months |
| Number of clinically significant changes in physical examinations | Up to 4 months |
| Number of clinically significant changes in clinical laboratory tests | Up to 4 months |
| Orlando |
| Florida |
| 32809 |
| United States |
| Prism Clinical Research | Saint Paul | Minnesota | 55114 | United States |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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