Clinical trial · Interventional
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
NCT06425198CI-TRIAL-00084959completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Participants | — | UNRESOLVED | — |
| Hepatic Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986278 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A: Mild Hepatic Impairment BMS-986278
- interventionNames
- Drug: BMS-986278
- type
- EXPERIMENTAL
- label
- Group B: Moderate Hepatic Impairment BMS-986278
- interventionNames
- Drug: BMS-986278
- type
- EXPERIMENTAL
- label
- Group C: Severe Hepatic Impairment BMS-986278
- interventionNames
- Drug: BMS-986278
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.