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Liver function and drug levels: a repotrectinib study

NCT ID NCT06352528

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a single dose of the drug repotrectinib stays in the blood of people with moderate or severe liver impairment compared to healthy volunteers. 18 adults took part to help understand if liver problems change drug levels. The results will guide dosing for patients with liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Apr 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Orlando Clinical Research Center

    Orlando, Florida, 32809-3017, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014-2811, United States

  • The Texas Liver Institute, Inc.

    San Antonio, Texas, 78215, United States

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