Loading clinical trials...

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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

An Open-label Parallel-Group Study to Evaluate Pharmacokinetics of E7090 and Its Metabolite in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects

NCT04271488•Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

20 - 79 years

Sex

ALL

Healthy Volunteers

Yes

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.
•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.
•1. Syphilis as demonstrated by positive serology at Screening.
+1 more criteria

Locations (8)

Eisai Trial Site #6

Hakata, Fukuoka, Japan

Eisai Trial Site #4

Kurume, Fukuoka, Japan

Eisai Trial Site #2

Yuhu, Oita Prefecture, Japan

Eisai Trial Site #3

Bukyo-ku, Tokyo, Japan

Eisai Trial Site #1

Mintato-ku, Tokyo, Japan

Eisai Trial Site #8

Shinjuku-ku, Tokyo, Japan

Eisai Trial Site #5

Kofu, Yamanashi, Japan

Eisai Trial Site #7

Kyoto, Japan

Key Dates

Start Date

February 27, 2020

Primary Completion Date

November 30, 2026

Completion Date

November 30, 2026

Last Updated

January 23, 2026

Enrollment

ESTIMATED participants

Conditions

Hepatic Impairment

Interventions

Tasurgratinib

DRUG

Tasurgratinib

DRUG

Contacts

Inquiry Service.

CONTACT

eisai-chiken_hotline@hhc.eisai.co.jp

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616

Hepatic Impairment (HI)

View study

RECRUITINGPHASE1

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

NCT06952634

Hepatic Impairment

View study

COMPLETEDPHASE1

A Varegacestat Hepatic Impairment Study

NCT06841315

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

A Varegacestat Hepatic Impairment Study

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function