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

February 6, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Xuhui Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort SHR3824/Placebo 1.25 mg
SHR3824 1.25 mg/day or placebo for 10 days.
Drug: Placebo
Drug: SHR3824
Other Names:
  • Henagliflozin
Experimental: Cohort SHR3824/Placebo 2.5 mg
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.
Drug: Placebo
Drug: SHR3824
Other Names:
  • Henagliflozin
Experimental: Cohort SHR3824/Placebo 5 mg
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.
Drug: Placebo
Drug: SHR3824
Other Names:
  • Henagliflozin
Experimental: Cohort SHR3824/Placebo 10 mg
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.
Drug: Placebo
Drug: SHR3824
Other Names:
  • Henagliflozin
Experimental: Cohort SHR3824/Placebo 25 mg
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.
Drug: Placebo
Drug: SHR3824
Other Names:
  • Henagliflozin
Experimental: Cohort SHR3824/Placebo 100mg
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.
Drug: Placebo
Drug: SHR3824
Other Names:
  • Henagliflozin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, vital signs, physical exams , ECG, clinical labs
Time Frame: Days -14 to -1, 0, 13.
Days -14 to -1, 0, 13.
Serum creatinine
Time Frame: Days -14 to -1, 0, 2, 9, 13.
Days -14 to -1, 0, 2, 9, 13.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 1, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR3824-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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