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

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: Healthy Volunteers; Hepatic Impairment
• Intervention / Treatment: Drug: Repotrectinib

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with vital sign abnormalities	Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 11
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 clinical safety laboratory test abnormalities	Up to Day 11

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

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: Pharmacokinetics; Healthy Volunteers; Liver Diseases; Hepatic Impairment; Severe; Repotrectinib; BMS-986472
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Digestive System Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Liver Diseases; Lymphoma, Follicular; repotrectinib
• 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