About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m²).
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Tasurgratinib
DrugTasurgratinib oral tablet.
Tasurgratinib
DrugTasurgratinib oral capsule.
Treatment groups
Trial outcomes
Primary outcomes
Cmax: Maximum Observed Plasma Concentration of Tasurgratinib
AUC(0-t): Area Under the Plasma Concentration versus Time Curve from Time 0 to Time of Last Quantifiable Concentration of Tasurgratinib
AUC(0-inf): Area Under the Plasma Concentration versus Time Curve from Time 0 to Infinity of Tasurgratinib
Secondary outcomes
Tmax: Time to Reach Maximum Plasma Concentration of Tasurgratinib and its Metabolite
AUC(0-72Hours): Area Under the Plasma Concentration versus Time Curve from Time 0 to 72 Hours of Tasurgratinib and its Metabolite
T1/2: Terminal Phase Plasma Half-life of Tasurgratinib and its Metabolite
CL/F: Apparent Total Body Clearance of Tasurgratinib
Sponsors and contacts
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