Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Hepatic Impairment; Healthy Participants

Treatments: Drug: BMS-986278

Study type: Interventional

Funder types: Industry

Identifiers

NCT06425198

IM027-1009

Details and patient eligibility

About

The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All Participants:

• Must have a body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.

Mild, Moderate, or Severe Hepatic Impairment Participants:

• Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
• Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.

Matched Healthy Participants:

• Free of any clinically significant disease that would interfere with the study evaluations.
• Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).

Exclusion criteria

All Participants:

• History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).

Mild, Moderate, or Severe Hepatic Impairment Participants:

• Acute liver disease (eg, caused by an acute infection or drug toxicity).
• History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.

Matched Healthy Participants:

• Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
• 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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48 participants in 4 patient groups

Group A: Mild Hepatic Impairment BMS-986278

Experimental group

Treatment:

Drug: BMS-986278

Group B: Moderate Hepatic Impairment BMS-986278

Experimental group

Treatment:

Drug: BMS-986278

Group C: Severe Hepatic Impairment BMS-986278

Experimental group

Treatment:

Drug: BMS-986278

Group D: Normal Hepatic Function BMS-986278

Experimental group

Treatment:

Drug: BMS-986278