Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT04293029

SHR0302-106

Details and patient eligibility

About

Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Normal liver function

Experimental group

Description:

Patients will receive single dose of SHR0302

Treatment:

Drug: SHR0302

Mild Hepatic Impairment

Experimental group

Description:

Patients will receive single dose of SHR0302

Treatment:

Drug: SHR0302

Moderate Hepatic Impairment

Experimental group

Description:

Patients will receive single dose of SHR0302

Treatment:

Drug: SHR0302