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NCT06425198CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 22 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
37 (actual)
First submitted
17 May 2024
Start date
10 Jun 2024
Primary completion date
30 Dec 2024
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT06425198

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 37
  • From 10 Jun 2024 to the primary completion date, 30 Dec 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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:
  • History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
    • Matched Healthy Participants:

Other illness

  • Acute liver disease (eg, caused by an acute infection or drug toxicity).
  • Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.

Other

  • All Participants:
  • Other protocol-defined inclusion/exclusion criteria apply.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
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Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
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Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
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Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.