Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: SHR3824

Study type: Interventional

Funder types: Industry

Identifiers

NCT03160014

SHR3824-109

Details and patient eligibility

About

Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years to 75 years (inclusive)
• Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
• Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)

Exclusion criteria

• allergic to SGLT2 inhibitor analogues or any other similar structure;
• lactose intolerance history or lactose intolerance;
• Suspected or diagnosed as liver cancer or with other malignant tumors;
• Alcoholic liver, autoimmune liver disease, liver transplantation history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

healthy volunteers

Experimental group

Description:

Drug: SHR3824 20mg/day, oral tablet, single dose

Treatment:

Drug: SHR3824

Mild Hepatic Impairment

Experimental group

Description:

Drug: SHR3824 20mg/day, oral tablet, single dose

Treatment:

Drug: SHR3824

Moderate Hepatic Impairment

Experimental group

Description:

Drug: SHR3824 20mg/day, oral tablet, single dose

Treatment:

Drug: SHR3824

Severe Hepatic Impairment

Experimental group

Description:

Drug: SHR3824 20mg/day, oral tablet, single dose

Treatment:

Drug: SHR3824