Back to resultsSafety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
Primary Purpose
Hepatic Impairment
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR3824
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
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
Sites / Locations
- XiJing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
healthy volunteers
Mild Hepatic Impairment
Moderate Hepatic Impairment
Severe Hepatic Impairment
Arm Description
Drug: SHR3824 20mg/day, oral tablet, single dose
Drug: SHR3824 20mg/day, oral tablet, single dose
Drug: SHR3824 20mg/day, oral tablet, single dose
Drug: SHR3824 20mg/day, oral tablet, single dose
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03160014
First Posted
May 17, 2017
Last Updated
May 17, 2017
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03160014
Brief Title
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
Official Title
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
healthy volunteers
Arm Type
Experimental
Arm Description
Drug: SHR3824 20mg/day, oral tablet, single dose
Arm Title
Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Drug: SHR3824 20mg/day, oral tablet, single dose
Arm Title
Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Drug: SHR3824 20mg/day, oral tablet, single dose
Arm Title
Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
Drug: SHR3824 20mg/day, oral tablet, single dose
Intervention Type
Drug
Intervention Name(s)
SHR3824
Intervention Description
Drug: SHR3824 20mg/day, oral tablet, single dose
Primary Outcome Measure Information:
Title
The area under the plasma concentration-time curve (AUC) of SHR3824
Description
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
Time Frame
72 hours after dosing
Title
The maximum plasma concentration (Cmax) of SHR3824
Description
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.
Time Frame
72 hours after dosing
Secondary Outcome Measure Information:
Title
The number of volunteers with adverse events as a measure of safety and tolerability
Description
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame
72 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XinMin Zhou
Phone
029-84775507
Facility Information:
Facility Name
XiJing Hospital
City
XiAn
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
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