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

Phase 1

• Conditions: Renal Insufficiency,Type 2 Diabetes
• Interventions: Drug: SHR3824

• Registration Number: NCT03159832
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2016-06
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Last Update Submitted: 2017-05-17
• Study First Posted: 2017-05-19
• Last Update Posted: 2017-05-19
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function	SHR3824	All subjects were given SHR3824 20mg only one time.
Mild renal dysfunction	SHR3824	All subjects were given SHR3824 20mg only one time.
Moderate renal dysfunction	SHR3824	All subjects were given SHR3824 20mg only one time.

Primary Outcome Measures

Name	Time	Method
The area under the plasma concentration-time curve (AUC) of SHR3824	72 hours after dosing	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
The maximum plasma concentration (Cmax) of SHR3824	72 hours after dosing	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

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	72 hours after dosing	The number of volunteers with adverse events as a measure of safety and tolerability

Trial Locations

Locations (1)

Chinese people's liberation army general hospital of Chengdu military area; 🇨🇳 Chengdu, Sichuan, China