A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm A: Normal Renal Function
Intervention: BMS-986259 (Drug)
Arm B: Mild Renal Impairment
Intervention: BMS-986259 (Drug)
Arm C: Moderate Renal Impairment
Intervention: BMS-986259 (Drug)
Arm D: Severe Renal Impairment
Intervention: BMS-986259 (Drug)
Outcomes
Primary Outcomes
Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Time Frame: Day 1 and Day 8
Concentration of BMS-986259 in blood serum at 24 hours (C24)
Time Frame: 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)
Time Frame: Day 8
Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
Time Frame: Day 8
Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
Time Frame: Day 8
Terminal elimination half-life of BMS-986259 (T-HALF)
Time Frame: Day 8
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)
Time Frame: Day 8
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
Time Frame: Day 8
Apparent total clearance of BMS-986259 at steady-state (CLss/F)
Time Frame: Day 8
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
Time Frame: Day 1 and Day 8
Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)
Time Frame: Day 1 and Day 8
Secondary Outcomes
- 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)
- 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)