An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
Primary Purpose
Cardiac Failure, Myocardial Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986224
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Failure
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- BMI ≥18 and ≤ 35kg/m2
- Systolic blood pressure >100 mmHg
Exclusion Criteria:
- Women of childbearing potential or women who are currently pregnant
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- Clinical Pharmacology of Miami
- Orlando Clinical Research Center
- Prism Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Normal Renal Function
Mild Renal Impairment
Moderate Renal Impairment
Severe Renal Impairment
End-Stage Renal Disease (ESRD)
Arm Description
ESRD participants and are on chronic hemodialysis
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of BMS-986224
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
Fraction of unbound drug in plasma (fu) of BMS-986224
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
Part 1 only
Fraction of dose excreted in urine (Fe%) of BMS-986224
Part 1 only
Renal clearance of BMS-986224 derived from urine concentration
Part 1 only
Secondary Outcome Measures
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Maximum observed plasma concentration (Cmax) of metabolite
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite
Time of maximum observed plasma concentration (Tmax) of metabolite
Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration
Metabolite-to-parent (MR) ratio for cMax
Metabolite-to-parent (MR) ratio for AUC(0-T)
Metabolite-to-parent (MR) ratio for AUC(0-72)
Metabolite-to-parent (MR) ratio for AUC(INF)
Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests
Full Information
NCT ID
NCT03634969
First Posted
August 15, 2018
Last Updated
February 24, 2020
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03634969
Brief Title
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
Official Title
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (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
5. Study Description
Brief Summary
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure, Myocardial Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Title
End-Stage Renal Disease (ESRD)
Arm Type
Experimental
Arm Description
ESRD participants and are on chronic hemodialysis
Intervention Type
Drug
Intervention Name(s)
BMS-986224
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of BMS-986224
Time Frame
Up to 11 days
Title
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
Time Frame
Up to 11 days
Title
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224
Time Frame
Up to 11 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Time Frame
Up to 11 days
Title
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Time Frame
Up to 11 days
Title
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
Time Frame
Up to 11 days
Title
Fraction of unbound drug in plasma (fu) of BMS-986224
Time Frame
Up to 11 days
Title
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
Time Frame
Up to 11 days
Title
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
Time Frame
Up to 11 days
Title
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
Description
Part 1 only
Time Frame
7 days
Title
Fraction of dose excreted in urine (Fe%) of BMS-986224
Description
Part 1 only
Time Frame
7 days
Title
Renal clearance of BMS-986224 derived from urine concentration
Description
Part 1 only
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time Frame
Up to 41 days
Title
Maximum observed plasma concentration (Cmax) of metabolite
Time Frame
Up to 11 days
Title
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite
Time Frame
Up to 11 days
Title
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite
Time Frame
Up to 11 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite
Time Frame
Up to 11 days
Title
Time of maximum observed plasma concentration (Tmax) of metabolite
Time Frame
Up to 11 days
Title
Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration
Time Frame
Up to 11 days
Title
Metabolite-to-parent (MR) ratio for cMax
Time Frame
Up to 11 days
Title
Metabolite-to-parent (MR) ratio for AUC(0-T)
Time Frame
Up to 11 days
Title
Metabolite-to-parent (MR) ratio for AUC(0-72)
Time Frame
Up to 11 days
Title
Metabolite-to-parent (MR) ratio for AUC(INF)
Time Frame
Up to 11 days
Title
Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests
Time Frame
Up to 11 days
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:
BMI ≥18 and ≤ 35kg/m2
Systolic blood pressure >100 mmHg
Exclusion Criteria:
Women of childbearing potential or women who are currently pregnant
Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
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
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 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
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
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