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

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

A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Drug: BMS-986259

Detailed Description

Recruitment temporarily on hold due to COVID-19

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	Day 8
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)	Day 8

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: CV019-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No