Actively Recruiting

Phase 1
Age: 20Years - 79Years
All Genders
Healthy Volunteers
NCT04271488

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

Age: 20Years - 79Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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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