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Completed

NCT Number: NCT06425198

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to day 9

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

    Time frame: Up to day 9

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

    Time frame: Up to day 9

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 62 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 62 days

  3. Number of participants with physical examination abnormalities

    Time frame: Up to 62 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 62 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 62 days

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 62 days

  7. Time of maximum observed concentration (Tmax)

    Time frame: Up to day 9

  8. Terminal elimination half-life (T-HALF)

    Time frame: Up to day 9

  9. Apparent body clearance (CLT/F)

    Time frame: Up to day 9

  10. Maximum observed plasma concentration of unbound drug (Cmax_u)

    Time frame: Up to day 9

  11. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]

    Time frame: Up to day 9

  12. Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]

    Time frame: Up to day 9

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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