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NCT06352528CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
18 (actual)
First submitted
3 Apr 2024
Start date
29 Apr 2024
Primary completion date
16 Sept 2025
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT06352528

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 18
  • From 29 Apr 2024 to the primary completion date, 16 Sept 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any major surgery within 4 weeks of the study intervention administration.
  • 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.

Other illness

  • History of drug abuse within 1 year of study intervention administration.
  • History of alcohol abuse within 1 year of study intervention administration.

Other

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

Who the study is looking for

  • \- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.
  • Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.
  • 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):.
  • Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
  • 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):.
  • Participant must be free of any clinically significant disease that would interfere with the study evaluations.
  • Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Panax Clinical Research
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Orlando Clinical Research Center
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
The Texas Liver Institute, Inc.
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.