Skip to main content
OpenTrials
Completed

NCT Number: NCT04634149

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Moderate Liver Impairment Digestive System Diseases Fatty Liver Fibrosis Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Liver Impairment

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986036

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 29 days

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 29 days

  3. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T))

    Time frame: Up to 29 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 31 days

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 31 days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 31 days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 31 days

  5. Number of participants with physical examination abnormalities

    Time frame: Up to 31 days

  6. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 29 days

  7. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 29 days

  8. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T))

    Time frame: Up to 29 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.