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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: SHR3824; Drug: Placebo

• Registration Number: NCT02361138
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-12
• Study First Submitted: 2015-02-01
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-11
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort SHR3824/Placebo 1.25 mg	SHR3824	SHR3824 1.25 mg/day or placebo for 10 days.
Cohort SHR3824/Placebo 1.25 mg	Placebo	SHR3824 1.25 mg/day or placebo for 10 days.
Cohort SHR3824/Placebo 2.5 mg	SHR3824	SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 2.5 mg	Placebo	SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 5 mg	SHR3824	SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 5 mg	Placebo	SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 10 mg	SHR3824	SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 10 mg	Placebo	SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 25 mg	SHR3824	SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 25 mg	Placebo	SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 100mg	Placebo	SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 100mg	SHR3824	SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.

Primary Outcome Measures

Name	Time	Method
AUC(Area under the curve) of SHR3824.	day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.	day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.	day1 and day11 to day 13.
Halflife of SHR3824.	day1 and day11 to day 13.
CL/F of SHR3824.	day1 and day11 to day 13.
V/F of SHR3824.	day1 and day11 to day 13.
Accumulation ratio of SHR3824	Up to day 13.
Urine glucose concentration of SHR3824.	day1 and day11
Plasma glucose concentration of SHR3824.	day1 and day11

Secondary Outcome Measures

Name	Time	Method
Adverse events, vital signs, physical exams , ECG, clinical labs	Days -14 to -1, 0, 13.
Serum creatinine	Days -14 to -1, 0, 2, 9, 13.

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, Shanghai, China