---
title: Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
nct_id: NCT06425198
overall_status: COMPLETED
phase: PHASE1
sponsor: Bristol-Myers Squibb
study_type: INTERVENTIONAL
primary_condition: Hepatic Impairment
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06425198.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06425198"
ct_last_update_post_date: 2025-01-22
last_seen_at: "2026-05-12T06:37:33.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06425198](https://clinicaltrials.gov/study/NCT06425198)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 37
- **Lead Sponsor:** Bristol-Myers Squibb
- **Conditions:** Hepatic Impairment, Healthy Participants
- **Start Date:** 2024-06-10
- **Completion Date:** 2024-12-30
- **CT.gov Last Update:** 2025-01-22

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Group A: Mild Hepatic Impairment BMS-986278** (EXPERIMENTAL)
- **Group B: Moderate Hepatic Impairment BMS-986278** (EXPERIMENTAL)
- **Group C: Severe Hepatic Impairment BMS-986278** (EXPERIMENTAL)
- **Group D: Normal Hepatic Function BMS-986278** (EXPERIMENTAL)

## Interventions

- **BMS-986278** (DRUG) — Specified dose on specified days

## 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)_

## Locations (4)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.local institution - 0001|miami lakes|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 0003|orlando|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 0002|tampa|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 0004|san antonio|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06425198.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06425198*  
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