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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-79
SponsorEisai Co., Ltd.

About this trial

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

Qualifiers

Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m²).

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tasurgratinib
  • Tasurgratinib

Treatment groups

18 Participants
are divided into 3 treatment groups

Sponsors and collaborators