CompletedNCT06425198Updated Jan 22, 2025

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

A Phase 1 interventional study of BMS-986278 in Hepatic Impairment and Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Dec 2024, 1 year 9 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 37
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Hepatic Impairment
Healthy Participants

Browse trials for

Keywords

Healthy Volunteers
Pharmacokinetics
Liver Diseases
Mild, Moderate and Severe Hepatic Impairment
BMS-986278

In context

Liver Diseases

2,094 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 37 is below the median of 50 across 1,328 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Group A: Mild Hepatic Impairment BMS-986278
Drug: BMS-986278
Experimental
Group B: Moderate Hepatic Impairment BMS-986278
Drug: BMS-986278
Experimental
Group C: Severe Hepatic Impairment BMS-986278
Drug: BMS-986278
Experimental
Group D: Normal Hepatic Function BMS-986278
Drug: BMS-986278

Interventions

DrugBMS-986278
Specified dose on specified days

What researchers measure

Primary outcomes

Maximum observed concentration (Cmax)
Time frame: Up to day 9
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
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to day 9

Secondary outcomes

Incidence of adverse events (AEs)
Time frame: Up to 62 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 62 days
Number of participants with physical examination abnormalities
Time frame: Up to 62 days
Number of participants with vital sign abnormalities
Time frame: Up to 62 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 62 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 62 days
Time of maximum observed concentration (Tmax)
Time frame: Up to day 9
Terminal elimination half-life (T-HALF)
Time frame: Up to day 9
Apparent body clearance (CLT/F)
Time frame: Up to day 9
Maximum observed plasma concentration of unbound drug (Cmax_u)
Time frame: Up to day 9
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
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

Study locations

4 sites

Local Institution - 0001
Miami Lakes, Florida 33027, United States
Local Institution - 0003
Orlando, Florida 32809, United States
Local Institution - 0002
Tampa, Florida 33618, United States
Local Institution - 0004
San Antonio, Texas 78215, United States

References and documents

Individual participant data

Plan to share: No — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06425198
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: May 22, 2024
Start date: Jun 10, 2024
Primary completion: Dec 30, 2024
Completion: Dec 30, 2024
Last update: Jan 22, 2025

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Admilparant

Other studies in this condition

Liver Diseases →

Other studies from this sponsor

Bristol-Myers Squibb →

Start the discussion