[Translation] Phase I clinical study on the pharmacokinetics and safety of CS0159 tablets in subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function
主要研究目的:评估CS0159在轻度肝功能不全(Child-Pugh:A级)、中度肝功能不全(Child-Pugh:B级)和性别、年龄、体重匹配的肝功能正常的健康受试者中的药代动力学特征,为肝功能不全受试者的合理临床用药提供科学依据。
次要研究目的:评价CS0159在轻度肝功能不全(Child-Pugh:A级)、中度肝功能不全(Child-Pugh:B级)和肝功能正常的健康受试者中的安全性。
探究性目的:评估基线肝功能指标与CS0159的PK参数的相关性。
[Translation] Primary study objective: To evaluate the pharmacokinetic characteristics of CS0159 in healthy subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function matched by gender, age and weight, and to provide a scientific basis for the rational clinical use of drugs in subjects with hepatic impairment.
Secondary study objective: To evaluate the safety of CS0159 in healthy subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function.
Exploratory objective: To evaluate the correlation between baseline liver function indicators and PK parameters of CS0159.