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

Primary Purpose

Renal Failure

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986259
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Pharmacology of Miami
  • Orlando Clinical Research Center
  • Prism Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A: Normal Renal Function

Arm B: Mild Renal Impairment

Arm C: Moderate Renal Impairment

Arm D: Severe Renal Impairment

Arm Description

Outcomes

Primary Outcome Measures

Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)
Concentration of BMS-986259 in blood serum at 24 hours (C24)
Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)
Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
Terminal elimination half-life of BMS-986259 (T-HALF)
Apparent total clearance of BMS-986259 at steady-state (CLss/F)
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)

Secondary Outcome Measures

Incidence of Non serious Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of AEs leading to discontinuation
Number of clinically significant changes in vital signs
Number in clinically significant changes in Electrocardiogram (ECG)
Number of clinically significant changes in physical examinations
Number of clinically significant changes in clinical laboratory tests

Full Information

First Posted
January 19, 2020
Last Updated
September 20, 2021
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04237831
Brief Title
A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Normal Renal Function
Arm Type
Experimental
Arm Title
Arm B: Mild Renal Impairment
Arm Type
Experimental
Arm Title
Arm C: Moderate Renal Impairment
Arm Type
Experimental
Arm Title
Arm D: Severe Renal Impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986259
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
Time Frame
Day 1 and Day 8
Title
Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
Time Frame
Day 1 and Day 8
Title
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
Title
Concentration of BMS-986259 in blood serum at 24 hours (C24)
Time Frame
Day 1 and Day 8
Title
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
Title
Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
Time Frame
Day 8
Title
Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
Time Frame
Day 8
Title
Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
Time Frame
Day 8
Title
Terminal elimination half-life of BMS-986259 (T-HALF)
Time Frame
Day 8
Title
Apparent total clearance of BMS-986259 at steady-state (CLss/F)
Time Frame
Day 8
Title
Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Incidence of Non serious Adverse Events (AEs)
Time Frame
Up to 4 months
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 4 months
Title
Incidence of AEs leading to discontinuation
Time Frame
Up to 4 months
Title
Number of clinically significant changes in vital signs
Time Frame
Up to 4 months
Title
Number in clinically significant changes in Electrocardiogram (ECG)
Time Frame
Up to 4 months
Title
Number of clinically significant changes in physical examinations
Time Frame
Up to 4 months
Title
Number of clinically significant changes in clinical laboratory tests
Time Frame
Up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Prism Clinical Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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