Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient

Study Overview
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Brief Summary
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The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.

Detailed Description
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This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.

Official Title
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Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)

Conditions
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Renal Insufficiency,Type 2 Diabetes

Intervention / Treatment
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* Drug: SHR3824


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with a body mass index(BMI) between 19 and 33 Kg/m2; The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2. Had signed the informed consent himself or herself voluntarily. Exclusion Criteria: Urinary tract infections, or vulvovaginal mycotic infections Suspected or diagnosed as kidney cancer or other malignancies in patients Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated History of or current clinically significant medical illness as determined by the Investigator History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose Known allergy to SHR3824,SGLT2 inhibitor analogs, or any other structural analogs Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day. Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal renal function<br>All subjects were given SHR3824 20mg only one time. | Drug: SHR3824<br>* All subjects were given SHR3824 20mg only one time.<br>|
| Active Comparator: Mild renal dysfunction<br>All subjects were given SHR3824 20mg only one time. | Drug: SHR3824<br>* All subjects were given SHR3824 20mg only one time.<br>|
| Active Comparator: Moderate renal dysfunction<br>All subjects were given SHR3824 20mg only one time. | Drug: SHR3824<br>* All subjects were given SHR3824 20mg only one time.<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 renal function patients and mild or moderate renal 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 renal function patients and mild or moderate renal 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, PK/PD study, Renal Insufficiency, Type 2 Diabetes