Phase
Condition
Primary Biliary Cholangitis
Treatment
Tasurgratinib
Clinical Study ID
Ages 20-79 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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-Pughclassification A and B.
For Cohort C: healthy participants matched to participants with hepatic impairmentwith regard to age (+/-10 years), body weight (+/-20 percent [%]), race and gender,and as determined by no clinically significant deviation from normal in medicalhistory, physical examination, electrocardiogram (ECG), and clinical laboratorydeterminations.
Exclusion
Exclusion Criteria:
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 maculardegeneration, 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 greaterthan (>) 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:
Any significant acute medical illness (such as new conditions or exacerbation ofpre-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 tohepatic disease has not remained stable/unchanged for at least two weeks beforedosing 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 oninvestigators opinion.
Study Design
Connect with a study center
Eisai Trial Site #4
Kurume, Fukuoka
JapanSite Not Available
Eisai Trial Site #6
Hakata, Fukuoka 1863958
JapanActive - Recruiting
Eisai Trial Site #4
Kurume 1858088, Fukuoka 1863958
JapanTerminated
Eisai Trial Site #2
Yufu, Oita
JapanSite Not Available
Eisai Trial Site #2
Yuhu, Oita Prefecture 1854484
JapanActive - Recruiting
Eisai Trial Site #3
Bunkyō-Ku, Tokyo
JapanSite Not Available
Eisai Trial Site #1
Minato-Ku, Tokyo
JapanSite Not Available
Eisai Trial Site #3
Bukyo-ku, Tokyo 1850144
JapanActive - Recruiting
Eisai Trial Site #1
Mintato-ku, Tokyo 1850144
JapanActive - Recruiting
Eisai Trial Site #8
Shinjuku-ku, Tokyo 1850144
JapanActive - Recruiting
Eisai Trial Site #5
Kofu, Yamanashi
JapanSite Not Available
Eisai Trial Site #5
Kofu 1859100, Yamanashi 1848649
JapanActive - Recruiting
Eisai Trial Site #7
Kyoto 1857910,
JapanActive - Recruiting

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