Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
NCT ID: NCT06425198
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2024-06-10
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Mild Hepatic Impairment BMS-986278
BMS-986278
Specified dose on specified days
Group B: Moderate Hepatic Impairment BMS-986278
BMS-986278
Specified dose on specified days
Group C: Severe Hepatic Impairment BMS-986278
BMS-986278
Specified dose on specified days
Group D: Normal Hepatic Function BMS-986278
BMS-986278
Specified dose on specified days
Interventions
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BMS-986278
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Miami Lakes, Florida, United States
Local Institution - 0003
Orlando, Florida, United States
Local Institution - 0002
Tampa, Florida, United States
Local Institution - 0004
San Antonio, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM027-1009
Identifier Type: -
Identifier Source: org_study_id
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