A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function

Phase 1

Completed

• Conditions: Renal Failure
• Interventions: Drug: BMS-986259

• Registration Number: NCT04237831
• Lead Sponsor: Bristol-Myers Squibb

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-23
• Study Start: 2020-02-26
• Primary Completion: 2021-07-16
• Study Completion: 2021-07-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm C: Moderate Renal Impairment	BMS-986259	-
Arm A: Normal Renal Function	BMS-986259	-
Arm B: Mild Renal Impairment	BMS-986259	-
Arm D: Severe Renal Impairment	BMS-986259	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum	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 concentration of BMS-986259 at 24 hours- AR(C24)	Day 8
Terminal elimination half-life of BMS-986259 (T-HALF)	Day 8
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)	Day 8
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])	Day 8
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum	Day 1 and Day 8
Apparent total clearance of BMS-986259 at steady-state (CLss/F)	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Prism Clinical Research; 🇺🇸 Saint Paul, Minnesota, United States