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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04271488

Enrollment

Registered

2020-02-17

Start date

2020-02-27

Completion date

2027-08-31

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment, E7090, Tasurgratinib

Brief 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.

Interventions

DRUGTasurgratinib

Tasurgratinib oral tablet.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

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. Additional

Design outcomes

Primary

Measure	Time frame
Cmax: Maximum Observed Plasma Concentration of Tasurgratinib	Day 1: 0-144 hours postdose
AUC(0-t): Area Under the Plasma Concentration versus Time Curve from Time 0 to Time of Last Quantifiable Concentration of Tasurgratinib	Day 1: 0-144 hours postdose
AUC(0-inf): Area Under the Plasma Concentration versus Time Curve from Time 0 to Infinity of Tasurgratinib	Day 1: 0-144 hours postdose

Secondary

Measure	Time frame
Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite	Day 1: 0-144 hours postdose
AUC(0-72Hours): Area Under the Plasma Concentration versus Time Curve from Time 0 to 72 Hours of Tasurgratinib and its Metabolite	Day 1: 0-144 hours postdose
T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite	Day 1: 0-144 hours postdose
CL/F: Apparent Total Body Clearance of Tasurgratinib	Day 1: 0-144 hours postdose
Vz/F : Apparent Volume of Distribution at Terminal Phase of Tasurgratinib	Day 1: 0-144 hours postdose
AUC Metabolite Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of Tasurgratinib, Corrected for Molecular Weights	Day 1: 0-144 hours postdose
fu: Plasma Protein Unbound Fraction of Tasurgratiniband its Metabolite	Day 1: 0-144 hours postdose
AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Tasurgratinib	Day 1: 0-144 hours postdose
CLu/F: Apparent Clearance Relative to the Unbound Plasma Concentration of Based on AUCu of Tasurgratinib	Day 1: 0-144 hours postdose

Countries

Japan

Contacts

CONTACTInquiry Service.

eisai-chiken_hotline@hhc.eisai.co.jp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026