Actively Recruiting
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
Led by Eisai Co., Ltd. · Updated on 2026-01-23
18
Participants Needed
8
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m^2).
- For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.
- For Cohort C: healthy participants matched to participants with hepatic impairment by age (+/-10 years), body weight (+/-20%), race, and gender with no clinically significant abnormalities in medical history, physical exam, ECG, or labs.
You will not qualify if you...
- Current evidence of Grade 2 or higher corneal disorder.
- Current evidence of active macular disorder such as Age-related macular degeneration or central serous chorioretinal disease.
- Known to be HIV positive at screening.
- QTcF interval greater than 480 milliseconds on ECG.
- For hepatic impairment cohorts: any significant acute illness within 8 weeks before dosing.
- Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy.
- Unstable or changed liver-related therapy within 2 weeks before dosing.
- For healthy participants: positive syphilis serology at screening.
- Any abnormal physical exam, vital signs, ECG, or lab results requiring treatment or follow-up as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Eisai Trial Site #6
Hakata, Fukuoka, Japan
Actively Recruiting
2
Eisai Trial Site #4
Kurume, Fukuoka, Japan
Terminated
3
Eisai Trial Site #2
Yuhu, Oita Prefecture, Japan
Actively Recruiting
4
Eisai Trial Site #3
Bukyo-ku, Tokyo, Japan
Actively Recruiting
5
Eisai Trial Site #1
Mintato-ku, Tokyo, Japan
Actively Recruiting
6
Eisai Trial Site #8
Shinjuku-ku, Tokyo, Japan
Actively Recruiting
7
Eisai Trial Site #5
Kofu, Yamanashi, Japan
Actively Recruiting
8
Eisai Trial Site #7
Kyoto, Japan
Actively Recruiting
Research Team
I
Inquiry Service.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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