Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）
研究概览
简要总结
Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects:：
- •Signing the informed consent forms；
- •18 years to 65 years (inclusive)；
- •Body mass index should be between 18 and 30 kg/m2 (inclusive)；
- •No medication was used before screening，or stable medication for 4 weeks.
- •Normal liver function：
- •Clinical laboratory tests during the screening period were normal，or the abnormality has no clinical significance.
- •Hepatic impaired subjects:
- •Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
- •Liver damage due to primary liver disease.
排除标准
- •All subjects:
- •Subject known or suspected of being sensitive to the study drugs or its ingredient；
- •Normal liver function：
- •Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
- •Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.
- •Hepatic impaired subjects:
- •Suspected or diagnosed as liver cancer or with other malignant tumors;
- •Drug induced liver injury，acute liver injury，liver transplantation history.
- •Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
研究组 & 干预措施
Normal liver function
Patients will receive single dose of SHR0302
干预措施: SHR0302 (Drug)
Mild Hepatic Impairment
Patients will receive single dose of SHR0302
干预措施: SHR0302 (Drug)
Moderate Hepatic Impairment
Patients will receive single dose of SHR0302
干预措施: SHR0302 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）
时间窗: 72 hours after dosing
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Peak Plasma Concentration (Cmax)
时间窗: 72 hours after dosing
Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t）
时间窗: 72 hours after dosing
Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
次要结局
- Adverse events(72 hours after dosing)