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

NCT06425198 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1009
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatic Impairment; Healthy Participants

Keywords

Healthy Volunteers; Pharmacokinetics; Liver Diseases; Mild, Moderate and Severe Hepatic Impairment; BMS-986278

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Incidence of adverse events (AEs)

  Up to 62 days

• Incidence of serious adverse events (SAEs)

  Up to 62 days

• 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

Study Arms (4)

Group A: Mild Hepatic Impairment BMS-986278

EXPERIMENTAL

Drug: BMS-986278

Group B: Moderate Hepatic Impairment BMS-986278

EXPERIMENTAL

Drug: BMS-986278

Group C: Severe Hepatic Impairment BMS-986278

EXPERIMENTAL

Drug: BMS-986278

Group D: Normal Hepatic Function BMS-986278

EXPERIMENTAL

Drug: BMS-986278

Interventions

BMS-986278 DRUG

Specified dose on specified days

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Local Institution - 0001

Miami Lakes, Florida, 33027, United States

Location

Local Institution - 0003

Orlando, Florida, 32809, United States

Location

Local Institution - 0002

Tampa, Florida, 33618, United States

Location

Local Institution - 0004

San Antonio, Texas, 78215, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Liver Diseases; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Digestive System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: June 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)