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

Primary Purpose

Renal Insufficiency,Type 2 Diabetes

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR3824
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency,Type 2 Diabetes focused on measuring Efficacy, PK/PD study, Renal Insufficiency, Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese people's liberation army general hospital of Chengdu military areaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Normal renal function

Mild renal dysfunction

Moderate renal dysfunction

Arm Description

All subjects were given SHR3824 20mg only one time.

All subjects were given SHR3824 20mg only one time.

All subjects were given SHR3824 20mg only one time.

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 renal function patients and mild or moderate renal dysfunction patients
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

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

First Posted
May 17, 2017
Last Updated
May 17, 2017
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03159832
Brief Title
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient
Official Title
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (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

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency,Type 2 Diabetes
Keywords
Efficacy, PK/PD study, Renal Insufficiency, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal renal function
Arm Type
Active Comparator
Arm Description
All subjects were given SHR3824 20mg only one time.
Arm Title
Mild renal dysfunction
Arm Type
Active Comparator
Arm Description
All subjects were given SHR3824 20mg only one time.
Arm Title
Moderate renal dysfunction
Arm Type
Active Comparator
Arm Description
All subjects were given SHR3824 20mg only one time.
Intervention Type
Drug
Intervention Name(s)
SHR3824
Intervention Description
All subjects were given SHR3824 20mg only one time.
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 renal function patients and mild or moderate renal 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 renal function patients and mild or moderate renal 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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Liu, Phd
Phone
+86-15705155025
Facility Information:
Facility Name
Chinese people's liberation army general hospital of Chengdu military area
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaolan yong

12. IPD Sharing Statement

Learn more about this trial

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

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