A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

NCT06352528 | Completed Phase 1 FDA Drug

• 1 other identifier: CA127-1070
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Hepatic Impairment; Healthy Volunteers; Severe; BMS-986472; Repotrectinib; Liver Diseases; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Maximum observed plasma concentration (Cmax)

  Days 1 to 11

• Time of maximum observed plasma concentration (Tmax)

  Days 1 to 11

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Days 1 to 11

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

  Days 1 to 11

Secondary Outcomes (6)

• Number of participants with Adverse Events (AEs)

  Up to 28 days following last dose

• Number of participants with Severe Adverse Events (SAEs)

  Up to 28 days following last dose

• Number of participants with physical examination abnormalities

  Up to Day 11

• Number of participants with vital sign abnormalities

  Up to Day 11

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 11

Study Arms (3)

Group 1: Moderate Hepatic Impairment

EXPERIMENTAL

Drug: Repotrectinib

Group 2: Severe Hepatic Impairment

EXPERIMENTAL

Drug: Repotrectinib

Group 3: Normal Hepatic Function

EXPERIMENTAL

Drug: Repotrectinib

Interventions

Repotrectinib DRUG

Specified dose on specified days

Also known as: BMS-986472

Group 1: Moderate Hepatic Impairment; Group 2: Severe Hepatic Impairment; Group 3: Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i) Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.
• ii) Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.
• i) Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
• ii) Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.
• i) Participant must be free of any clinically significant disease that would interfere with the study evaluations.
• ii) Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
• iii) Participant must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator.

You may not qualify if:

• i) Any major surgery within 4 weeks of the study intervention administration.
• ii) History of drug abuse within 1 year of study intervention administration.
• iii) History of alcohol abuse within 1 year of study intervention administration.
• iv) Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Panax Clinical Research

Miami Lakes, Florida, 33014-2811, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

The Texas Liver Institute, Inc.

San Antonio, Texas, 78215, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Follicular; Liver Diseases

Interventions

repotrectinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 8, 2024
• Study Start: April 29, 2024
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (3)