Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants
Recruiting
Phase 1Interventional Study
Hepatic Impairment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 79
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Eisai Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for people with mild to moderate liver problems to study how a single dose of tasurgratinib affects them. Healthy participants will also be included for comparison.
Are You a Good Fit for This Trial?
You may be able to join if
I have a body mass index (BMI) between 18 and 40.
I have stable mild or moderate liver impairment.
I am a healthy participant matched by age, weight, race, and gender.
You may not be able to join if
I have a serious eye condition.
I am HIV positive.
I have a prolonged QT interval on my ECG.
I have had a serious illness in the past 8 weeks.
I have severe swelling or confusion related to my liver problems.
My liver medication has not been stable for at least two weeks.
I have syphilis.
I have abnormal test results needing treatment based on a doctor’s opinion.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.
Trial Locations
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Eligibility Criteria
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 …
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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