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

NCT ID: NCT03159832

Last Updated: 2017-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Renal Insufficiency,Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal renal function

All subjects were given SHR3824 20mg only one time.

Group Type: ACTIVE_COMPARATOR

SHR3824

Intervention Type: DRUG

All subjects were given SHR3824 20mg only one time.

Mild renal dysfunction

All subjects were given SHR3824 20mg only one time.

Group Type: ACTIVE_COMPARATOR

SHR3824

Intervention Type: DRUG

All subjects were given SHR3824 20mg only one time.

Moderate renal dysfunction

All subjects were given SHR3824 20mg only one time.

Group Type: ACTIVE_COMPARATOR

SHR3824

Intervention Type: DRUG

All subjects were given SHR3824 20mg only one time.

Interventions

SHR3824

All subjects were given SHR3824 20mg only one time.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese people's liberation army general hospital of Chengdu military area

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyan Liu, Phd

Role: CONTACT

+86-15705155025

Facility Contacts

xiaolan yong

Role: primary

Other Identifiers

SHR3824-110

Identifier Type: -

Identifier Source: org_study_id