Evaluating the effects of tasurgratinib in patients with mild to moderate liver impairment

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

This study tests how well the drug tasurgratinib works in people with mild to moderate liver problems compared to healthy individuals.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 20 Years to 79 Years
• Sex: All
• Sponsor: Eisai Inc. (industry)
• Drugs / interventions: tasurgratinib
• Locations: 8 sites (Hakata, Fukuoka and 7 other locations)
• Trial ID: NCT04271488 on ClinicalTrials.gov

What this trial studies

This study aims to assess how mild and moderate hepatic impairment affects the pharmacokinetics of tasurgratinib after a single dose administration. Participants with stable hepatic impairment will be compared to healthy individuals matched by age, weight, race, and gender. The study will involve administering tasurgratinib and monitoring its absorption, distribution, metabolism, and excretion in the body. The findings could provide insights into the drug's safety and efficacy in patients with liver conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals with mild to moderate hepatic impairment classified as Child-Pugh A or B, as well as healthy participants matched to these individuals.

Not a fit: Patients with severe hepatic impairment or significant ocular disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with hepatic impairment by providing crucial pharmacokinetic data for tasurgratinib.

How similar studies have performed: While studies evaluating pharmacokinetics in hepatic impairment are common, the specific evaluation of tasurgratinib in this context is novel.

Eligibility criteria

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 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 of pre-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 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:

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 on investigators opinion.

Where this trial is running

Hakata, Fukuoka and 7 other locations

• Eisai Trial Site #6 — Hakata, Fukuoka, Japan (RECRUITING)
• Eisai Trial Site #4 — Kurume, Fukuoka, Japan (TERMINATED)
• Eisai Trial Site #2 — Yuhu, Oita Prefecture, Japan (RECRUITING)
• Eisai Trial Site #3 — Bukyo-ku, Tokyo, Japan (RECRUITING)
• Eisai Trial Site #1 — Mintato-ku, Tokyo, Japan (RECRUITING)
• Eisai Trial Site #8 — Shinjuku-ku, Tokyo, Japan (RECRUITING)
• Eisai Trial Site #5 — Kofu, Yamanashi, Japan (RECRUITING)
• Eisai Trial Site #7 — Kyoto, Japan (RECRUITING)

Study contacts

• Study coordinator: Inquiry Service.

Conditions: Hepatic Impairment, E7090, Tasurgratinib