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A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

Primary Purpose

Myocardial Failure, Cardiac Failure, Congestive Heart Failure

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986231
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Failure

Eligibility Criteria

18 Years - 70 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:

  • Body weight ≥ 45 kg and ≤ 120 kg
  • BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2
  • Heart rate ≥ 50 bpm and < 95 bpm
  • Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
  • No changes in medication within 30 days prior to study drug administration

Exclusion Criteria:

  • Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
  • History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
  • History of headaches related to caffeine withdrawal
  • History of migraine or cluster headaches
  • Patients requiring dialysis will not be enrolled in this study

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Local Institution
  • Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
  • Specjalistyczne Centrum Medyczne Panacea Poznan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild Renal Impairment

Moderate renal impairment

Severe renal impairment

Normal renal function

Arm Description

Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2

Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2

Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis

Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) derived from plasma concentration
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
Clearance (CL) derived from plasma concentration
Renal clearance (CLR) derived from urine concentration

Secondary Outcome Measures

Number of adverse events (AE)
Number of serious adverse events (SAE)
Terminal elimination half-life (t1/2)
Time of maximum observed plasma concentration (Tmax)
AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)
Terminal elimination phase rate constant (λz)
Volume of distribution during terminal phase (Vz)
Fraction of administered drug excreted into urine (Fe)
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)

Full Information

First Posted
November 2, 2017
Last Updated
September 10, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03332186
Brief Title
A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function
Official Title
A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Subjects With Varying Degrees of Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
October 22, 2018 (Actual)
Study Completion Date
October 22, 2018 (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
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Kidney Failure, Renal Failure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Description
Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Description
Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2
Arm Title
Severe renal impairment
Arm Type
Experimental
Arm Description
Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis
Arm Title
Normal renal function
Arm Type
Experimental
Arm Description
Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2
Intervention Type
Drug
Intervention Name(s)
BMS-986231
Intervention Description
Intravenous infusion administration
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) derived from plasma concentration
Time Frame
11 days
Title
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
Time Frame
11 days
Title
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
Time Frame
11 days
Title
Clearance (CL) derived from plasma concentration
Time Frame
11 days
Title
Renal clearance (CLR) derived from urine concentration
Time Frame
11 days
Secondary Outcome Measure Information:
Title
Number of adverse events (AE)
Time Frame
Up to 31 days
Title
Number of serious adverse events (SAE)
Time Frame
Up to 31 days
Title
Terminal elimination half-life (t1/2)
Time Frame
Up to 36 hours
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 36 hours
Title
AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)
Time Frame
Up to 36 hours
Title
Terminal elimination phase rate constant (λz)
Time Frame
Up to 36 hours
Title
Volume of distribution during terminal phase (Vz)
Time Frame
Up to 36 hours
Title
Fraction of administered drug excreted into urine (Fe)
Time Frame
Up to 36 hours
Title
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)
Time Frame
Up to 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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: Body weight ≥ 45 kg and ≤ 120 kg BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2 Heart rate ≥ 50 bpm and < 95 bpm Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment No changes in medication within 30 days prior to study drug administration Exclusion Criteria: Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months History of headaches related to caffeine withdrawal History of migraine or cluster headaches Patients requiring dialysis will not be enrolled in this study Other protocol defined inclusion/exclusion criteria could 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
Local Institution
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Specjalistyczne Centrum Medyczne Panacea Poznan
City
Krakow
ZIP/Postal Code
31-559
Country
Poland

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 of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

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