Back to resultsA Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986263
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- BMI ≥ 18 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]).
- Participants with normal hepatic function as judged by the investigator
- Participants with hepatic impairment as judged by the investigator
Exclusion Criteria:
- 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 participant.
- Any major surgery within 4 weeks of study drug administration
- Previous exposure to BMS-986263
Other protocol-defined inclusion/exclusion criteria apply.
Sites / Locations
- The Texas Liver Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A: Mild Hepatic Impairment
Group B: Moderate Hepatic Impairment
Group C: Severe Hepatic Impairment
Group D: Normal Hepatic function (control group)
Group E: Normal Hepatic Function (optional, control group)
Arm Description
Part 1
Part 1
Part 2
Part 1
Part 2
Outcomes
Primary Outcome Measures
Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection
Total body clearance (CL) of components of BMS-986263 for injection
Volume of distribution (Vz) of components of BMS-986263 for injection
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection
Secondary Outcome Measures
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of AEs leading to discontinuation
Number of participants with abnormalities in clinical laboratory assessments
Number of participants with vital sign abnormalities
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Number of participants with physical examination abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04225936
Brief Title
A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment
Official Title
An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 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
The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Part 1
Arm Title
Group B: Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Part 1
Arm Title
Group C: Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
Part 2
Arm Title
Group D: Normal Hepatic function (control group)
Arm Type
Experimental
Arm Description
Part 1
Arm Title
Group E: Normal Hepatic Function (optional, control group)
Arm Type
Experimental
Arm Description
Part 2
Intervention Type
Drug
Intervention Name(s)
BMS-986263
Intervention Description
Single Dose
Primary Outcome Measure Information:
Title
Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection
Time Frame
Day 1 to Day 31
Title
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
Time Frame
Day 1 to Day 31
Title
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection
Time Frame
Day 1 to Day 31
Title
Total body clearance (CL) of components of BMS-986263 for injection
Time Frame
Day 1 to Day 31
Title
Volume of distribution (Vz) of components of BMS-986263 for injection
Time Frame
Day 1 to Day 31
Title
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection
Time Frame
Day 1 to Day 31
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 31 days
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 59 days or up to 30 days after dosing (whichever is longer)
Title
Incidence of AEs leading to discontinuation
Time Frame
Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).
Title
Number of participants with abnormalities in clinical laboratory assessments
Time Frame
Up to 59 days
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 59 days
Title
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time Frame
Up to 59 days
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 59 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 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 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]).
Participants with normal hepatic function as judged by the investigator
Participants with hepatic impairment as judged by the investigator
Exclusion Criteria:
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 participant.
Any major surgery within 4 weeks of study drug administration
Previous exposure to BMS-986263
Other protocol-defined 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
The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
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.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment
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