This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03159832
First received: May 17, 2017
Last updated: NA
Last verified: June 2016
History: No changes posted
  Purpose
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.

Condition Intervention Phase
Renal Insufficiency,Type 2 Diabetes Drug: SHR3824 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)

Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • The area under the plasma concentration-time curve (AUC) of SHR3824 [ Time Frame: 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 [ Time Frame: 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:
  • The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: 72 hours after dosing ]
    The number of volunteers with adverse events as a measure of safety and tolerability


Estimated Enrollment: 24
Study Start Date: June 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03159832

Contacts
Contact: Haiyan Liu, Phd +86-15705155025

Locations
China, Sichuan
Chinese people's liberation army general hospital of Chengdu military area Recruiting
Chengdu, Sichuan, China
Contact: xiaolan yong         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03159832     History of Changes
Other Study ID Numbers: SHR3824-110
Study First Received: May 17, 2017
Last Updated: May 17, 2017

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Efficacy
PK/PD study
Renal Insufficiency
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 22, 2017