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

Phase 1

Completed

• Conditions: Hepatic Impairment; Healthy Participants
• Interventions: Drug: BMS-986278

• Registration Number: NCT06425198
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Study Start: 2024-06-10
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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%).
• Must not have had any prior exposure to BMS-986278.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration of unbound drug (Cmax_u)	Up to day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]	Up to day 9
Incidence of serious adverse events (SAEs)	Up to 62 days
Incidence of adverse events (AEs)	Up to 62 days
Time of maximum observed concentration (Tmax)	Up to day 9
Apparent body clearance (CLT/F)	Up to day 9
Number of participants with clinical laboratory abnormalities	Up to 62 days
Terminal elimination half-life (T-HALF)	Up to day 9
Number of participants with physical examination abnormalities	Up to 62 days
Number of participants with vital sign abnormalities	Up to 62 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 62 days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]	Up to day 9

Trial Locations

Locations (4)

Local Institution - 0002; 🇺🇸 Tampa, Florida, United States

Local Institution - 0001; 🇺🇸 Miami Lakes, Florida, United States

Local Institution - 0003; 🇺🇸 Orlando, Florida, United States

Local Institution - 0004; 🇺🇸 San Antonio, Texas, United States