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

February 4, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Single 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 single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

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, 200031
        • 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 acception 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 1
SHR3824 2.5 mg/day or placebo.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Experimental: Cohort 2
SHR3824 5 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Experimental: Cohort 3
SHR3824 10 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Experimental: Cohort 4
SHR3824 25 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Experimental: Cohort 5
SHR3824 50 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Experimental: Cohort 6
SHR3824 100 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Experimental: Cohort 7
SHR3824 200 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
Drug: SHR3824
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Other Names:
  • Henagliflozin
Drug: Placebo
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.
Time Frame: 24h after dosing
24h after dosing
SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.
Time Frame: Up to 72h after dosing
Up to 72h after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of patients with adverse events as a measure of safety and tolerability
Time Frame: up to day 72h after dosing
up to day 72h after dosing

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

June 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR3824-101

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.

Subscribe