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

NCT04271488 | Recruiting Phase 1

• 1 other identifier: E7090-J081-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Hepatic Impairment

Keywords

Hepatic Impairment; E7090; Tasurgratinib

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration of Tasurgratinib

  Day 1: 0-144 hours postdose

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

  Day 1: 0-144 hours postdose

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

  Day 1: 0-144 hours postdose

Secondary Outcomes (9)

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

  Day 1: 0-144 hours postdose

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

  Day 1: 0-144 hours postdose

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

  Day 1: 0-144 hours postdose

• CL/F: Apparent Total Body Clearance of Tasurgratinib

  Day 1: 0-144 hours postdose

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

  Day 1: 0-144 hours postdose

Study Arms (3)

Cohort A: Mild Hepatic Impairment (Child Pugh Class A)

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single 35 milligram (mg) tablet of tasurgratinib in the morning with 150 milliliters (mL) of water following an overnight fast of at least 10 hours.

Drug: Tasurgratinib

Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)

EXPERIMENTAL

Participants with moderate hepatic impairment will receive 10 mg dose of tasurgratinib as capsule (2 capsules each of 5 mg) in the morning with 150 mL of water following an overnight fast of at least 10 hours.

Drug: Tasurgratinib

Cohort C: Healthy Participants (Control)

EXPERIMENTAL

Healthy participants matched to participants with hepatic impairment in Cohorts A and B (matched with regards to age, race, gender and body weight) will receive a single 35 mg tablet of tasurgratinib in the morning with 150 mL of water following an overnight fast of at least 10 hours.

Drug: Tasurgratinib

Interventions

Tasurgratinib DRUG

Tasurgratinib oral tablet.

Cohort A: Mild Hepatic Impairment (Child Pugh Class A); Cohort C: Healthy Participants (Control)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (8)

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

Central Study Contacts

Inquiry Service.

CONTACT

eisai-chiken_hotline@hhc.eisai.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 27, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (8)