[Translation] A Phase I clinical study to compare the pharmacokinetics, pharmacodynamics, and safety of intravenous methoxyetomidate hydrochloride for injection in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and normal hepatic function
主要研究目的:
评价注射用甲氧依托咪酯盐酸盐在轻度肝功能不全受试者(Child-Pugh A)、中度肝功能不全受试者(Child-Pugh B)和肝功能正常受试者中的药代动力学特征,为甲氧依托咪酯盐酸盐在肝功能损害患者中的临床应用提供依据。
次要研究目的:
评价注射用甲氧依托咪酯盐酸盐在轻度肝功能不全受试者(Child-Pugh A)、中度肝功能不全受试者(Child-Pugh B)和肝功能正常受试者中的安全性和药效动力学。
探索性研究目的:
探索并分析本研究中在不同肝功能状态下的受试者中药效学指标(MOAA/S、BIS)与甲氧依托咪酯盐酸盐药代动力学参数的关系。
分析研究中受试者的 CYP2C19 的基因型,根据 CYP2C19 基因型的数据探索基因多态性对甲氧依托咪酯盐酸盐药代动力学参数的影响。
分析甲氧依托咪酯盐酸盐体内暴露与肝脏损伤之间的关系。
[Translation] Main study objectives:
To evaluate the pharmacokinetic characteristics of methoxyetomidate hydrochloride for injection in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B) and normal liver function, and to provide a basis for the clinical application of methoxyetomidate hydrochloride in patients with liver impairment.
Secondary study objectives:
To evaluate the safety and pharmacodynamics of methoxyetomidate hydrochloride for injection in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B) and normal liver function.
Exploratory study objectives:
To explore and analyze the relationship between pharmacodynamic indicators (MOAA/S, BIS) and pharmacokinetic parameters of methoxyetomidate hydrochloride in subjects with different liver function status in this study.
To analyze the genotype of CYP2C19 of the subjects in the study, and to explore the effect of genetic polymorphism on the pharmacokinetic parameters of methoxyetomidate hydrochloride based on the data of CYP2C19 genotype.
To analyze the relationship between in vivo exposure to methoxyetomidate hydrochloride and liver damage.