The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers

Type 2 Diabetes Clinical Trial

— SHR3824  

Official title:

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Single Dose of SHR3824 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356224
• Other study ID #: SHR3824-101
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2015
• Last updated: February 4, 2015
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• Chinese male and female subjects aged 18 to 45 years.

• BMI:18 -25 kg/m2 .

• Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria:

• 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.

• Pregnancy or breastfeeding .

• Significant acute or chronic medical illness, including renal impairment, or recent surgery.

• Donation of blood or plasma within the 4 weeks prior to the start of the study or acception of blood transfusion within 8 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
• Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.		24h after dosing	No
Primary	SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.		Up to 72h after dosing	No
Secondary	The number of patients with adverse events as a measure of safety and tolerability		up to day 72h after dosing	Yes