## Protocol Section
### Identification Module
**NCT ID:** NCT06425198

**Brief Title:** 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

#### Organization Study ID Info
**ID:** IM027-1009
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2024-12-23

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-23

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hepatic Impairment

- Healthy Participants

**Keywords:**

- Healthy Volunteers

- Pharmacokinetics

- Liver Diseases

- Mild, Moderate and Severe Hepatic Impairment

- BMS-986278

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BMS-986278

**Label:** Group A: Mild Hepatic Impairment BMS-986278

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: BMS-986278

**Label:** Group B: Moderate Hepatic Impairment BMS-986278

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: BMS-986278

**Label:** Group C: Severe Hepatic Impairment BMS-986278

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: BMS-986278

**Label:** Group D: Normal Hepatic Function BMS-986278

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A: Mild Hepatic Impairment BMS-986278

- Group B: Moderate Hepatic Impairment BMS-986278

- Group C: Severe Hepatic Impairment BMS-986278

- Group D: Normal Hepatic Function BMS-986278

**Description:** Specified dose on specified days

**Name:** BMS-986278

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Maximum observed concentration (Cmax)

**Time Frame:** Up to day 9

**Measure:** 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

**Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

**Time Frame:** Up to day 9

#### Secondary Outcomes

**Measure:** Incidence of adverse events (AEs)

**Time Frame:** Up to 62 days

**Measure:** Incidence of serious adverse events (SAEs)

**Time Frame:** Up to 62 days

**Measure:** Number of participants with physical examination abnormalities

**Time Frame:** Up to 62 days

**Measure:** Number of participants with vital sign abnormalities

**Time Frame:** Up to 62 days

**Measure:** Number of participants with electrocardiogram (ECG) abnormalities

**Time Frame:** Up to 62 days

**Measure:** Number of participants with clinical laboratory abnormalities

**Time Frame:** Up to 62 days

**Measure:** Time of maximum observed concentration (Tmax)

**Time Frame:** Up to day 9

**Measure:** Terminal elimination half-life (T-HALF)

**Time Frame:** Up to day 9

**Measure:** Apparent body clearance (CLT/F)

**Time Frame:** Up to day 9

**Measure:** Maximum observed plasma concentration of unbound drug (Cmax_u)

**Time Frame:** 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]

**Time Frame:** 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]

**Time Frame:** Up to day 9

### Eligibility Module

**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%).

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.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain NCT # and Site #.

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** 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

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** BMS Clinical Trial Patient Recruiting

**URL:** https://www.bmsstudyconnect.com/s/US/English/USenHome

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11107

- Name: Liver Diseases

- Relevance: HIGH

- As Found: Hepatic Impairment

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008107

- Term: Liver Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
