Renal Failure
Conditions
Brief summary
A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function
Detailed description
Recruitment temporarily on hold due to COVID-19
Interventions
DRUGBMS-986259
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F) | 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) | Day 8 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Serious Adverse Events (SAEs) | Up to 4 months |
| Incidence of AEs leading to discontinuation | 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 |
| Incidence of Non serious Adverse Events (AEs) | Up to 4 months |
Countries
United States
Outcome results
None listed