Phase 1 Hepatic Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
Status:
Recruiting
Trial end date:
2024-04-30
Target enrollment:
Participant gender:
Summary
A Phase I clinical study to compare the pharmacokinetics, pharmacokinetics, and safety of
intravenous administration of methoxyetomidate hydrochloride for injection in subjects with
mild hepatic insufficiency (Child-pugh A), moderate hepatic insufficiency (Child-Pugh B), and
normal hepatic function.Main OBJECTIVE: To evaluate the pharmacokinetic characteristics of
metoetomidate hydrochloride for injection in subjects with mild liver dysfunction (Child-Pugh
A), moderate liver dysfunction (Child-Pugh B) and normal liver function, and to provide
evidence for the clinical application of metoetomidate hydrochloride in patients with liver
dysfunction.Secondary objective: To evaluate the safety and pharmacokinetics of metoetomidate
hydrochloride for injection in subjects with mild hepatic insufficiency (Child-Pugh A),
moderate hepatic insufficiency (Child-Pugh B), and normal hepatic dysfunction.Exploratory
objective: To investigate and analyze the relationship between the pharmacokinetic index
(MOAA/S, BIS) and the pharmacokinetic parameters of metoetomidate hydrochloride in subjects
with different liver function states in this study.The CYP2C19 genotype of the subjects in
the study was analyzed, and the influence of gene polymorphism on pharmacokinetic parameters
of metoetomidate hydrochloride was explored according to the data of CYP2C19 genotype.The
relationship between in vivo exposure to methoxyetomidate hydrochloride and liver injury was
analyzed.