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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2022-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate Liver Impairment Severe Liver Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Moderate Hepatic Impairment

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Group B: Severe Hepatic Impairment

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Group C: Normal Hepatic Function

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986036

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes