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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Renal Insufficiency,Type 2 Diabetes

Treatments: Drug: SHR3824

Study type: Interventional

Funder types: Industry

Identifiers

NCT03159832

SHR3824-110

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Normal renal function

Active Comparator group

Description:

All subjects were given SHR3824 20mg only one time.

Treatment:

Drug: SHR3824

Mild renal dysfunction

Active Comparator group

Description:

All subjects were given SHR3824 20mg only one time.

Treatment:

Drug: SHR3824

Moderate renal dysfunction

Active Comparator group

Description:

All subjects were given SHR3824 20mg only one time.

Treatment:

Drug: SHR3824