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

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

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

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: SHR3824


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy volunteers<br>Drug: SHR3824 20mg/day, oral tablet, single dose | Drug: SHR3824<br>* Drug: SHR3824 20mg/day, oral tablet, single dose<br>|
| Experimental: Mild Hepatic Impairment<br>Drug: SHR3824 20mg/day, oral tablet, single dose | Drug: SHR3824<br>* Drug: SHR3824 20mg/day, oral tablet, single dose<br>|
| Experimental: Moderate Hepatic Impairment<br>Drug: SHR3824 20mg/day, oral tablet, single dose | Drug: SHR3824<br>* Drug: SHR3824 20mg/day, oral tablet, single dose<br>|
| Experimental: Severe Hepatic Impairment<br>Drug: SHR3824 20mg/day, oral tablet, single dose | Drug: SHR3824<br>* Drug: SHR3824 20mg/day, oral tablet, single dose<br>|

What is the study measuring?
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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 |