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

Phase 1

• Conditions: Hepatic Impairment
• Interventions: Drug: SHR3824

• Registration Number: NCT03160014
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2016-06
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Last Update Submitted: 2017-05-17
• Study First Posted: 2017-05-19
• Last Update Posted: 2017-05-19
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	SHR3824	Drug: SHR3824 20mg/day, oral tablet, single dose
Mild Hepatic Impairment	SHR3824	Drug: SHR3824 20mg/day, oral tablet, single dose
Moderate Hepatic Impairment	SHR3824	Drug: SHR3824 20mg/day, oral tablet, single dose
Severe Hepatic Impairment	SHR3824	Drug: SHR3824 20mg/day, oral tablet, single dose

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SHR3824	72 hours after dosing	Cmax (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients.
The area under the plasma concentration-time curve (AUC) of SHR3824	72 hours after dosing	AUC (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	72 hours after dosing	The number of volunteers with adverse events as a measure of safety and tolerability

Trial Locations

Locations (1)

XiJing Hospital; 🇨🇳 XiAn, Shanxi, China