Clinical trial NCT06425198: Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Participants
Keywords: Healthy Volunteers
Pharmacokinetics
Liver Diseases
Mild, Moderate and Severe Hepatic Impairment
BMS-986278
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to day 9
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to day 9
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to day 9
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 62 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 62 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 62 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 62 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 62 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 62 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to day 9
measure: Terminal elimination half-life (T-HALF)
timeFrame: Up to day 9
measure: Apparent body clearance (CLT/F)
timeFrame: Up to day 9
measure: Maximum observed plasma concentration of unbound drug (Cmax_u)
timeFrame: Up to day 9
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]
timeFrame: Up to day 9
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]
timeFrame: Up to day 9
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Local Institution - 0001
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0003
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0002
state: Florida
city: San Antonio
country: United States
facility: Local Institution - 0004
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: