An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet
the full study eligibility criteria will be enrolled into the study. For each participant
with severe hepatic impairment, a corresponding healthy participant will be enrolled who
matches with regard to age, sex, BMI, and, if possible, smoking habit. A single dose of 55-mg
EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5
days (4 nights) in the study center for collection of blood samples and safety monitoring.
Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional
blood sampling and safety assessments. The study will measure and describe the concentrations
of EQ143 and its metabolite (HAS-719) in blood plasma over the course of 9 days (including
calculation of PK parameters), the degree of EQ143 binding to plasma proteins in blood, and
the safety of administering a single dose of EQ143 in severely hepatically impaired and
matched healthy participants.