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An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

Primary Purpose

Liver Dysfunction, Liver Insufficiency, Hepatic 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 Liver Dysfunction

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 and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
  • Heart rate ≥ 50 bpm and < 95 bpm
  • Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment

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 volunteer
  • History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
  • History of migraine or cluster headaches

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar
  • Clinical Research Unit Hungary
  • BioVirtus Centrum Medyczne
  • KO-MED Centra Kliniczne Lublin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild hepatic impairment

Moderate hepatic impairment

Severe hepatic impairment

Normal hepatic function

Arm Description

Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points

Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points

Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points

Based on Hepatic Function Impairment as defined by the investigator

Outcomes

Primary Outcome Measures

Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration
Maximum plasma concentration (Cmax)

Secondary Outcome Measures

Incidence of adverse events (AE)
Incidence of serious adverse events (SAE)
Incidence of Laboratory Test Result Abnormalities
Clearance (CL) derived from plasma concentration
Terminal elimination half-life (t1/2) derived from plasma concentration
Time of maximum observed plasma concentration (Tmax)
Terminal elimination phase rate constant (λz) derived from plasma concentration
Volume of distribution during terminal phase (Vz) derived from plasma concentration
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration

Full Information

First Posted
April 24, 2018
Last Updated
August 26, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03515980
Brief Title
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
Official Title
A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Participants With Varying Degrees of Hepatic Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
August 29, 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
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction, Liver Insufficiency, Hepatic Failure, Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Heart Decompensation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mild hepatic impairment
Arm Type
Experimental
Arm Description
Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points
Arm Title
Moderate hepatic impairment
Arm Type
Experimental
Arm Description
Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points
Arm Title
Severe hepatic impairment
Arm Type
Experimental
Arm Description
Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points
Arm Title
Normal hepatic function
Arm Type
Experimental
Arm Description
Based on Hepatic Function Impairment as defined by the investigator
Intervention Type
Drug
Intervention Name(s)
BMS-986231
Intervention Description
Intravenous (IV) administration
Primary Outcome Measure Information:
Title
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
Time Frame
Up to 2 days
Title
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration
Time Frame
Up to 2 days
Title
Maximum plasma concentration (Cmax)
Time Frame
Up to 2 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AE)
Time Frame
Up to 33 days
Title
Incidence of serious adverse events (SAE)
Time Frame
Up to 33 days
Title
Incidence of Laboratory Test Result Abnormalities
Time Frame
Up to 11 days
Title
Clearance (CL) derived from plasma concentration
Time Frame
Up to 2 days
Title
Terminal elimination half-life (t1/2) derived from plasma concentration
Time Frame
Up to 2 days
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 2 days
Title
Terminal elimination phase rate constant (λz) derived from plasma concentration
Time Frame
Up to 2 days
Title
Volume of distribution during terminal phase (Vz) derived from plasma concentration
Time Frame
Up to 2 days
Title
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration
Time Frame
Up to 2 days

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 and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2 Heart rate ≥ 50 bpm and < 95 bpm Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment 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 volunteer History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches History of migraine or cluster headaches 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
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Clinical Research Unit Hungary
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
BioVirtus Centrum Medyczne
City
Jozefow
ZIP/Postal Code
05-410
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin
City
Lublin
ZIP/Postal Code
20-954
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

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An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

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