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

NCT04634149 | Completed Phase 1 FDA Drug

• 1 other identifier: MB130-112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Moderate Liver Impairment; Severe Liver Impairment

Keywords

Cirrhosis; Hepatic impairment; Liver impairment; Nonalcoholic steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (3)

Group A: Moderate Hepatic Impairment

EXPERIMENTAL

Drug: BMS-986036

Group B: Severe Hepatic Impairment

EXPERIMENTAL

Drug: BMS-986036

Group C: Normal Hepatic Function

EXPERIMENTAL

Drug: BMS-986036

Interventions

BMS-986036 DRUG

Specified dose on specified days

Group A: Moderate Hepatic Impairment; Group B: Severe Hepatic Impairment; Group C: Normal Hepatic Function

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution - 0002

Miami, Florida, 33014, United States

Location

Local Institution

Orlando, Florida, 32809, United States

Location

Local Institution - 0001

San Antonio, Texas, 78215, United States

Location

Related Links

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

MeSH Terms

Conditions

Fibrosis; Non-alcoholic Fatty Liver Disease

Interventions

Pegbelfermin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: November 23, 2020
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

US (3)