Liver function and drug levels: a repotrectinib study
NCT ID NCT06352528
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Sep 2025
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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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
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Orlando Clinical Research Center
Orlando, Florida, 32809-3017, United States
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Panax Clinical Research
Miami Lakes, Florida, 33014-2811, United States
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The Texas Liver Institute, Inc.
San Antonio, Texas, 78215, United States
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