RecruitingPhase 1NCT04271488

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


Sponsor

Eisai Co., Ltd.

Enrollment

18 participants

Start Date

Feb 27, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 79 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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.
  • 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.
  • 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.

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Interventions

DRUGTasurgratinib

Tasurgratinib oral tablet.

DRUGTasurgratinib

Tasurgratinib oral capsule.


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

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NCT04271488


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