Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eisai Trial Site #6, Hakata, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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:

  • Following ocular disorders
  • Current evidence of Grade 2 or higher corneal disorder
  • Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)
  • Known to be human immunodeficiency virus (HIV) positive at Screening.
  • 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:

  • Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing.
  • Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy
  • 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:

  • Syphilis as demonstrated by positive serology at Screening.
  • 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.

Treatment and study plan

Tasurgratinib

Drug

Tasurgratinib oral tablet.

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

  2. AUC(0-t): Area Under the Plasma Concentration versus Time Curve from Time 0 to Time of Last Quantifiable Concentration of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

  3. AUC(0-inf): Area Under the Plasma Concentration versus Time Curve from Time 0 to Infinity of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

Secondary outcomes

  1. Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite

    Time frame: Day 1: 0-144 hours postdose

  2. AUC(0-72Hours): Area Under the Plasma Concentration versus Time Curve from Time 0 to 72 Hours of Tasurgratinib and its Metabolite

    Time frame: Day 1: 0-144 hours postdose

  3. T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite

    Time frame: Day 1: 0-144 hours postdose

  4. CL/F: Apparent Total Body Clearance of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

  5. Vz/F : Apparent Volume of Distribution at Terminal Phase of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

  6. AUC Metabolite Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of Tasurgratinib, Corrected for Molecular Weights

    Time frame: Day 1: 0-144 hours postdose

  7. fu: Plasma Protein Unbound Fraction of Tasurgratiniband its Metabolite

    Time frame: Day 1: 0-144 hours postdose

  8. AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

  9. CLu/F: Apparent Clearance Relative to the Unbound Plasma Concentration of Based on AUCu of Tasurgratinib

    Time frame: Day 1: 0-144 hours postdose

Study contacts

Contact information is provided by the study sponsor or research team.

Inquiry Service.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2020
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.