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

October 1, 2025 updated by: Bristol-Myers Squibb

A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Repotrectinib in Healthy Participants and Those With Moderate and Severe Hepatic Impairment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33014-2811
        • Panax Clinical Research
      • Orlando, Florida, United States, 32809-3017
        • Orlando Clinical Research Center
    • Texas
      • San Antonio, Texas, United States, 78215
        • The Texas Liver Institute, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.

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.

- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.

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.

- Inclusion Criteria for a Matched Healthy Participant (Group 3):.

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.

Exclusion Criteria:

- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.

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.

- Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Moderate Hepatic Impairment
Drug: Repotrectinib
Specified dose on specified days
Other Names:
  • BMS-986472
Experimental: Group 2: Severe Hepatic Impairment
Drug: Repotrectinib
Specified dose on specified days
Other Names:
  • BMS-986472
Experimental: Group 3: Normal Hepatic Function
Drug: Repotrectinib
Specified dose on specified days
Other Names:
  • BMS-986472

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Days 1 to 11
Days 1 to 11
Time of maximum observed plasma concentration (Tmax)
Time Frame: Days 1 to 11
Days 1 to 11
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: Days 1 to 11
Days 1 to 11
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Days 1 to 11
Days 1 to 11

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with vital sign abnormalities
Time Frame: Up to Day 11
Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to Day 11
Up to Day 11
Number of participants with Adverse Events (AEs)
Time Frame: Up to 28 days following last dose
Up to 28 days following last dose
Number of participants with Severe Adverse Events (SAEs)
Time Frame: Up to 28 days following last dose
Up to 28 days following last dose
Number of participants with physical examination abnormalities
Time Frame: Up to Day 11
Up to Day 11
Number of participants with clinical safety laboratory test abnormalities
Time Frame: Up to Day 11
Up to Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Actual)

September 16, 2025

Study Completion (Actual)

September 16, 2025

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA127-1070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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/disclosure-commitment.html

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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