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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Severe Liver Impairment; Moderate Liver Impairment

Treatments: Drug: BMS-986036

Study type: Interventional

Funder types: Industry

Identifiers

NCT04634149

MB130-112

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Group A: Moderate Hepatic Impairment

Experimental group

Treatment:

Drug: BMS-986036

Group B: Severe Hepatic Impairment

Experimental group

Treatment:

Drug: BMS-986036

Group C: Normal Hepatic Function

Experimental group

Treatment:

Drug: BMS-986036