Clinical trial

A Phase 1, Multi-center, Open-label Study to Assess the Pharmacokinetics and Safety of BMS-986278 in Healthy Participants and Those With Mild, Moderate and Severe Hepatic Impairment

Name

IM027-1009

Description

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.

Trial arms

Trial start

2024-06-10

Estimated PCD

2024-12-23

Trial end

2024-12-23

Status

Not yet recruiting

Phase

Early phase I

Treatment

BMS-986278

Specified dose on specified days

Arms:

Group A: Mild Hepatic Impairment BMS-986278, Group B: Moderate Hepatic Impairment BMS-986278, Group C: Severe Hepatic Impairment BMS-986278, Group D: Normal Hepatic Function BMS-986278

Size

Primary endpoint

Maximum observed concentration (Cmax)

Up to day 9

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

Up to day 9

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Up to day 9

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

Updated at

2024-05-22

1 organization

1 product

2 indications

Organization

Product

Indication

Indication