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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361138
• Other study ID #: SHR3824-102
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2015
• Last updated: February 6, 2015
• Start date: December 2013
• Est. completion date: May 2014

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 multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• 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 acceptance 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

• Placebo

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	AUC(Area under the curve) of SHR3824.		day1 and day11 to day 13.	No
Primary	Cmax(the maximum concentration) of SHR3824.		day1 and day11 to day 13.	No
Primary	Tmax(the time reaching maximum concentration) of SHR3824.		day1 and day11 to day 13.	No
Primary	Halflife of SHR3824.		day1 and day11 to day 13.	No
Primary	CL/F of SHR3824.		day1 and day11 to day 13.	No
Primary	V/F of SHR3824.		day1 and day11 to day 13.	No
Primary	Accumulation ratio of SHR3824		Up to day 13.	No
Primary	Urine glucose concentration of SHR3824.		day1 and day11	No
Primary	Plasma glucose concentration of SHR3824.		day1 and day11	No
Secondary	Adverse events, vital signs, physical exams , ECG, clinical labs		Days -14 to -1, 0, 13.	Yes
Secondary	Serum creatinine		Days -14 to -1, 0, 2, 9, 13.	Yes