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

Hepatic Impairment Clinical Trial

Official title:

Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03160014
• Other study ID #: SHR3824-109
• Status: Recruiting
• Phase: Phase 1
• First received: May 17, 2017
• Last updated: May 17, 2017
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: XinMin Zhou
• Phone: 029-84775507
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
China	XiJing Hospital	XiAn	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the plasma concentration-time curve (AUC) of SHR3824	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	72 hours after dosing
Primary	The maximum plasma concentration (Cmax) of SHR3824	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.	72 hours after dosing
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability	The number of volunteers with adverse events as a measure of safety and tolerability	72 hours after dosing