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.
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
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
8 sites in 1 country
Japan8 sites, 7 recruiting
- Recruiting
Eisai Trial Site #3
Bukyo-ku, Tokyo
- Recruiting
Eisai Trial Site #6
Hakata, Fukuoka
- Recruiting
Eisai Trial Site #5
Kofu, Yamanashi
- Terminated
Eisai Trial Site #4
Kurume, Fukuoka
- Recruiting
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
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.
- Conditions
- Hepatic Impairment
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Tasurgratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration of Tasurgratinib
Measured: 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
Measured: Day 1: 0-144 hours postdose
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)
Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite
Measured: 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
Measured: Day 1: 0-144 hours postdose
T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite
Measured: Day 1: 0-144 hours postdose
CL/F: Apparent Total Body Clearance of Tasurgratinib
Measured: Day 1: 0-144 hours postdose
Vz/F : Apparent Volume of Distribution at Terminal Phase of Tasurgratinib
Measured: Day 1: 0-144 hours postdose
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
fu: Plasma Protein Unbound Fraction of Tasurgratiniband its Metabolite
Measured: Day 1: 0-144 hours postdose
AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Tasurgratinib
Measured: Day 1: 0-144 hours postdose
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.
- First posted17 Feb 2020
- Study start27 Feb 2020
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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/.