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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425198
• Other study ID #: IM027-1009
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 10, 2024
• Est. completion date: December 23, 2024

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 23, 2024
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%).

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.

Related Conditions & MeSH terms

• Healthy Participants
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• BMS-986278
Specified dose on specified days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Up to day 9
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		Up to day 9
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]		Up to day 9
Secondary	Incidence of adverse events (AEs)		Up to 62 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 62 days
Secondary	Number of participants with physical examination abnormalities		Up to 62 days
Secondary	Number of participants with vital sign abnormalities		Up to 62 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 62 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 62 days
Secondary	Time of maximum observed concentration (Tmax)		Up to day 9
Secondary	Terminal elimination half-life (T-HALF)		Up to day 9
Secondary	Apparent body clearance (CLT/F)		Up to day 9
Secondary	Maximum observed plasma concentration of unbound drug (Cmax_u)		Up to day 9
Secondary	Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]		Up to day 9
Secondary	Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]		Up to day 9

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting