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Hepatic ImpairmentPhase 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

A Phase 1 study testing Tasurgratinib in people with Hepatic Impairment, run by Eisai Co., Ltd. at 8 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
Tasurgratinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
8 sitesJapan
Study dates
27 Feb 2020to 31 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Additional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B)
Show all 14Show fewer
  • In addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include:
  • 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.
  • 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:
  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Inquiry Service. contact

eisai-chiken_hotline@hhc.eisai.co.jp

8 sites in 1 country

Japan8 sites, 7 recruiting

  • Eisai Trial Site #3

    Bukyo-ku, Tokyo

    Recruiting

  • Eisai Trial Site #6

    Hakata, Fukuoka

    Recruiting

  • Eisai Trial Site #5

    Kofu, Yamanashi

    Recruiting

  • Eisai Trial Site #4

    Kurume, Fukuoka

    Terminated

  • Eisai Trial Site #7

    Kyoto

    Recruiting

  • Eisai Trial Site #1

    Mintato-ku, Tokyo

    Recruiting

  • Eisai Trial Site #8

    Shinjuku-ku, Tokyo

    Recruiting

  • Eisai Trial Site #2

    Yuhu, Oita Prefecture

    Recruiting

Other trials in Japan

About this study

Official title: 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

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.

Being tested
Tasurgratinib
Keywords
Hepatic Impairment, E7090, Tasurgratinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TasurgratinibDrug

    Tasurgratinib oral tablet.

  • TasurgratinibDrug

    Tasurgratinib oral capsule.

Study groups in NCT04271488
Study groupRoleWhat they receive
Cohort A: Mild Hepatic Impairment (Child Pugh Class A)ExperimentalParticipants 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.
Receives: Drug: Tasurgratinib
Cohort B: Moderate Hepatic Impairment (Child Pugh Class B)ExperimentalParticipants 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.
Receives: Drug: Tasurgratinib
Cohort C: Healthy Participants (Control)ExperimentalHealthy 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.
Receives: Drug: Tasurgratinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax: Maximum Observed Plasma Concentration of Tasurgratinib

    Measured: Day 1: 0-144 hours postdose

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

    Measured: Day 1: 0-144 hours postdose

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

    Measured: Day 1: 0-144 hours postdose

Secondary outcomes (9)

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

    Measured: Day 1: 0-144 hours postdose

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

    Measured: Day 1: 0-144 hours postdose

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

    Measured: Day 1: 0-144 hours postdose

  4. CL/F: Apparent Total Body Clearance of Tasurgratinib

    Measured: Day 1: 0-144 hours postdose

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

    Measured: Day 1: 0-144 hours postdose

  6. AUC Metabolite Ratio: Ratio of AUC(0-inf) of M2 to AUC(0-inf) of Tasurgratinib, Corrected for Molecular Weights

    Measured: Day 1: 0-144 hours postdose

  7. fu: Plasma Protein Unbound Fraction of Tasurgratiniband its Metabolite

    Measured: Day 1: 0-144 hours postdose

  8. AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Tasurgratinib

    Measured: Day 1: 0-144 hours postdose

  9. CLu/F: Apparent Clearance Relative to the Unbound Plasma Concentration of Based on AUCu of Tasurgratinib

    Measured: Day 1: 0-144 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start27 Feb 2020
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04271488
Sponsor's protocol ID
E7090-J081-001
Status last verified
Jan 2026
First submitted
13 Feb 2020
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tasurgratinib in people with Hepatic Impairment, run by Eisai Co., Ltd. at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Inquiry Service. (eisai-chiken_hotline@hhc.eisai.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration of Tasurgratinib (time frame: Day 1: 0-144 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04271488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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