Clinical trial NCT03159832: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Renal Insufficiency,Type 2 Diabetes
Keywords: Efficacy
PK/PD study
Renal Insufficiency
Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The area under the plasma concentration-time curve (AUC) of SHR3824
timeFrame: 72 hours after dosing
measure: The maximum plasma concentration (Cmax) of SHR3824
timeFrame: 72 hours after dosing
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: 72 hours after dosing
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chinese people's liberation army general hospital of Chengdu military area
state: Sichuan
Study officials:
References: