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

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

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

Study Overview

• Status: Unknown
• Conditions: Renal Insufficiency,Type 2 Diabetes
• Intervention / Treatment: Drug: SHR3824

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Chinese people's liberation army general hospital of Chengdu military area
      • Contact: Xiaolan Yong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal renal function; All subjects were given SHR3824 20mg only one time.	Drug: SHR3824; All subjects were given SHR3824 20mg only one time.
Active Comparator: Mild renal dysfunction; All subjects were given SHR3824 20mg only one time.	Drug: SHR3824; All subjects were given SHR3824 20mg only one time.
Active Comparator: Moderate renal dysfunction; All subjects were given SHR3824 20mg only one time.	Drug: SHR3824; All subjects were given SHR3824 20mg only one time.

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 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

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

• Keywords: Efficacy; Type 2 Diabetes; Renal Insufficiency; PK/PD study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency
• Other Study ID Numbers: SHR3824-110