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Liver Function's impact on drug breakdown under microscope

NCT ID NCT04271488

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This study looks at how mild and moderate liver problems change the way the body handles a single dose of the drug tasurgratinib. Researchers will compare 18 people with stable liver impairment to healthy volunteers matched by age, weight, race, and gender. The goal is to understand how the liver processes the drug, which helps guide safe 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

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Aug 2027

An estimate. End dates often move.

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

20 to 79 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: 1. Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m\^2). 2. For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B. 3. For Cohort C: healthy participants matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20 percent \[%\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations. Exclusion Criteria: Key Exclusion for all Participants: 1. Following ocular disorders 1. Current evidence of Grade 2 or higher corneal disorder 2. Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease) 2. Known to be human immunodeficiency virus (HIV) positive at Screening. 3. A prolonged QT/QTc interval (\[QT interval using Fridericia's formula\] QTcF greater than (\>) 480 millisecond \[ms\]) demonstrated on ECG. Additional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B) In addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include: 1. Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing. 2. Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy 3. The participant's standard therapy/concomitant medication for diseases related to hepatic disease has not remained stable/unchanged for at least two weeks before dosing of study drug. Additional Exclusion Criteria for Healthy participants (Cohort C) In addition to the Exclusion Criteria for all participants, other standard exclusion criteria for healthy participants in Phase 1 studies will be used. These include: 1. Syphilis as demonstrated by positive serology at Screening. 2. Any abnormal finding based on physical examination, assessment of vital signs, ECG, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Eisai Trial Site #1

    RECRUITING

    Mintato-ku, Tokyo, Japan

  • Eisai Trial Site #2

    RECRUITING

    Yuhu, Oita Prefecture, Japan

  • Eisai Trial Site #3

    RECRUITING

    Bukyo-ku, Tokyo, Japan

  • Eisai Trial Site #4

    TERMINATED

    Kurume, Fukuoka, Japan

  • Eisai Trial Site #5

    RECRUITING

    Kofu, Yamanashi, Japan

  • Eisai Trial Site #6

    RECRUITING

    Hakata, Fukuoka, Japan

  • Eisai Trial Site #7

    RECRUITING

    Kyoto, Japan

  • Eisai Trial Site #8

    RECRUITING

    Shinjuku-ku, Tokyo, Japan

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