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

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

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

Study Overview

• Status: Unknown
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: SHR3824

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi
    • XiAn, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy volunteers; Drug: SHR3824 20mg/day, oral tablet, single dose	Drug: SHR3824; Drug: SHR3824 20mg/day, oral tablet, single dose
Experimental: Mild Hepatic Impairment; Drug: SHR3824 20mg/day, oral tablet, single dose	Drug: SHR3824; Drug: SHR3824 20mg/day, oral tablet, single dose
Experimental: Moderate Hepatic Impairment; Drug: SHR3824 20mg/day, oral tablet, single dose	Drug: SHR3824; Drug: SHR3824 20mg/day, oral tablet, single dose
Experimental: Severe Hepatic Impairment; Drug: SHR3824 20mg/day, oral tablet, single dose	Drug: SHR3824; Drug: SHR3824 20mg/day, oral tablet, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: SHR3824-109