Liver Function's impact on drug breakdown under microscope
NCT ID NCT04271488
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
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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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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- 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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20 to 79 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.
Show the full entry requirements Hide 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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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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
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Eisai Trial Site #1
RECRUITINGMintato-ku, Tokyo, Japan
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Eisai Trial Site #2
RECRUITINGYuhu, Oita Prefecture, Japan
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Eisai Trial Site #3
RECRUITINGBukyo-ku, Tokyo, Japan
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Eisai Trial Site #4
TERMINATEDKurume, Fukuoka, Japan
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Eisai Trial Site #5
RECRUITINGKofu, Yamanashi, Japan
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Eisai Trial Site #6
RECRUITINGHakata, Fukuoka, Japan
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Eisai Trial Site #7
RECRUITINGKyoto, Japan
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Eisai Trial Site #8
RECRUITINGShinjuku-ku, Tokyo, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can two experimental drugs be used safely in people with cirrhosis?
- Can a damaged liver change how a new drug works?
- Liver health and drug processing: a closer look at casdatifan
- Liver function may change how belapectin works in the body
- Liver function may change how ammoxetine works