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Brief Summary:
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Failure | Drug: BMS-986259 | Phase 1 |
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| Study Type : | Interventional (Clinical Trial) |
| ActualEnrollment : | 30 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmaco*kinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function |
| Actual Study Start Date : | February 26, 2020 |
| Actual Primary Completion Date : | July 16, 2021 |
| Actual Study Completion Date : | July 16, 2021 |
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| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: Normal Renal Function | Drug: BMS-986259 Specified Dose on Specified Days |
| Experimental: Arm B: Mild Renal Impairment | Drug: BMS-986259 Specified Dose on Specified Days |
| Experimental: Arm C: Moderate Renal Impairment | Drug: BMS-986259 Specified Dose on Specified Days |
| Experimental: Arm D: Severe Renal Impairment | Drug: BMS-986259 Specified Dose on Specified Days |
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Primary Outcome Measures :
- Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum [TimeFrame:Day 1 and Day 8]
- Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum [TimeFrame:Day 1 and Day 8]
- Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU) [TimeFrame:Day 1 and Day 8]
- Concentration of BMS-986259 in blood serum at 24 hours (C24) [TimeFrame: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) [TimeFrame:Day 8]
- Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax) [TimeFrame:Day 8]
- Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU]) [TimeFrame:Day 8]
- Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24) [TimeFrame:Day 8]
- Terminal elimination half-life of BMS-986259 (T-HALF) [TimeFrame:Day 8]
- Apparent total clearance of BMS-986259 at steady-state (CLss/F) [TimeFrame:Day 8]
- Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F) [TimeFrame:Day 8]
Secondary Outcome Measures :
- Incidence of Non serious Adverse Events (AEs) [TimeFrame:Up to 4 months]
- Incidence of Serious Adverse Events (SAEs) [TimeFrame:Up to 4 months]
- Incidence of AEs leading to discontinuation [TimeFrame:Up to 4 months]
- Number of clinically significant changes in vital signs [TimeFrame:Up to 4 months]
- Number in clinically significant changes in Electrocardiogram (ECG) [TimeFrame:Up to 4 months]
- Number of clinically significant changes in physical examinations [TimeFrame:Up to 4 months]
- Number of clinically significant changes in clinical laboratory tests [TimeFrame:Up to 4 months]
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Information from the National Library of Medicine 
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
- No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
- Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
- Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
- Women and men must use highly effective methods of contraception for the duration of treatment
Exclusion Criteria:
- History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
- Positive results for drugs abuse in urine/saliva
- Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
- Known previous exposure to BMS-986259
Other inclusion/exclusion criteria apply
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237831
Locations
| United States, Florida | |
| Clinical Pharmacology of Miami | |
| Miami, Florida, United States, 33014 | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States, 32809 | |
| United States, Minnesota | |
| Prism Clinical Research | |
| Saint Paul, Minnesota, United States, 55114 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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Additional Information:
BMS Clinical Trial Information 
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04237831 |
| Other Study ID Numbers: | CV019-008 |
| First Posted: | January 23, 2020 Key Record Dates |
| Last Update Posted: | September 24, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Renal Insufficiency Kidney Diseases Urologic Diseases Female Urogenital Diseases | Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |
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