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Compares treatment options for Hepatic Impairment
Official title 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
ClinicalTrials.gov ID: NCT04271488
What this study is testing
What is Tasurgratinib?
Tasurgratinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatic impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 79. Healthy volunteers may be eligible.
You may be able to join 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 [%])...
You likely can't join if
- Key Exclusion for all Participants:
- 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...
See the full eligibility criteria
- 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...
- Key Exclusion for all Participants:
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hakata, Fukuoka, Japan
- Kurume, Fukuoka, Japan
- Yuhu, Oita Prefecture, Japan
- Bukyo-ku, Tokyo, Japan
- Mintato-ku, Tokyo, Japan
- Shinjuku-ku, Tokyo, Japan
- Kofu, Yamanashi, Japan
- Kyoto, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hakata, Fukuoka, Japan; Kurume, Fukuoka, Japan; Yuhu, Oita Prefecture, Japan; Bukyo-ku, Tokyo, Japan; Mintato-ku, Tokyo, Japan; Shinjuku-ku, Tokyo, Japan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.