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

Last updated: January 22, 2026
Sponsor: Eisai Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Tasurgratinib

Clinical Study ID

NCT04271488
E7090-J081-001
  • Ages 20-79
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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-Pughclassification A and B.

  3. For Cohort C: healthy participants matched to participants with hepatic impairmentwith regard to age (+/-10 years), body weight (+/-20 percent [%]), race and gender,and as determined by no clinically significant deviation from normal in medicalhistory, physical examination, electrocardiogram (ECG), and clinical laboratorydeterminations.

Exclusion

Exclusion Criteria:

Key Exclusion for all Participants:

  1. Following ocular disorders

  2. Current evidence of Grade 2 or higher corneal disorder

  3. Current evidence of active macular disorder (example, Age-related maculardegeneration, central serous chorioretinal disease)

  4. Known to be human immunodeficiency virus (HIV) positive at Screening.

  5. A prolonged QT/QTc interval ([QT interval using Fridericia's formula] QTcF greaterthan (>) 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:

  1. Any significant acute medical illness (such as new conditions or exacerbation ofpre-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 tohepatic disease has not remained stable/unchanged for at least two weeks beforedosing 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:

  1. Syphilis as demonstrated by positive serology at Screening.

  2. Any abnormal finding based on physical examination, assessment of vital signs, ECG,or laboratory test results that requires treatment or clinical follow up based oninvestigators opinion.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Tasurgratinib
Phase: 1
Study Start date:
February 27, 2020
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Eisai Trial Site #4

    Kurume, Fukuoka
    Japan

    Site Not Available

  • Eisai Trial Site #6

    Hakata, Fukuoka 1863958
    Japan

    Active - Recruiting

  • Eisai Trial Site #4

    Kurume 1858088, Fukuoka 1863958
    Japan

    Terminated

  • Eisai Trial Site #2

    Yufu, Oita
    Japan

    Site Not Available

  • Eisai Trial Site #2

    Yuhu, Oita Prefecture 1854484
    Japan

    Active - Recruiting

  • Eisai Trial Site #3

    Bunkyō-Ku, Tokyo
    Japan

    Site Not Available

  • Eisai Trial Site #1

    Minato-Ku, Tokyo
    Japan

    Site Not Available

  • Eisai Trial Site #3

    Bukyo-ku, Tokyo 1850144
    Japan

    Active - Recruiting

  • Eisai Trial Site #1

    Mintato-ku, Tokyo 1850144
    Japan

    Active - Recruiting

  • Eisai Trial Site #8

    Shinjuku-ku, Tokyo 1850144
    Japan

    Active - Recruiting

  • Eisai Trial Site #5

    Kofu, Yamanashi
    Japan

    Site Not Available

  • Eisai Trial Site #5

    Kofu 1859100, Yamanashi 1848649
    Japan

    Active - Recruiting

  • Eisai Trial Site #7

    Kyoto 1857910,
    Japan

    Active - Recruiting

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