A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment

The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.

Study Overview

• Status: Completed
• Conditions: Moderate Liver Impairment; Severe Liver Impairment
• Intervention / Treatment: Drug: BMS-986036

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Local Institution - 0002
    • Orlando, Florida, United States, 32809
      • Local Institution
  • Texas
    • San Antonio, Texas, United States, 78215
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations
• Body mass index (BMI) of 18.0 kg/m^2 to 40.0 kg/m^2, inclusive. BMI = weight (kg)/height (m^2)

Exclusion Criteria:

• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status
• History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Moderate Hepatic Impairment	Drug: BMS-986036; Specified dose on specified days
Experimental: Group B: Severe Hepatic Impairment	Drug: BMS-986036; Specified dose on specified days
Experimental: Group C: Normal Hepatic Function	Drug: BMS-986036; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 29 days
Time of maximum observed plasma concentration (Tmax)	Up to 29 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T))	Up to 29 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 29 days
Time of maximum observed plasma concentration (Tmax)	Up to 29 days
Number of participants with adverse events (AEs)	Up to 31 days
Number of participants with clinical laboratory abnormalities	Up to 31 days
Number of participants with vital sign abnormalities	Up to 31 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 31 days
Number of participants with physical examination abnormalities	Up to 31 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T))	Up to 29 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Cirrhosis; Hepatic impairment; Liver impairment; Nonalcoholic steatohepatitis (NASH)
• Other Study ID Numbers: MB130-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No