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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR3824
Placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring SHR3824 Type 2 diabetes mellitus SGLT2

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Xuhui Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Arm Description

SHR3824 2.5 mg/day or placebo.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.
SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.

Secondary Outcome Measures

The number of patients with adverse events as a measure of safety and tolerability

Full Information

First Posted
January 29, 2015
Last Updated
February 4, 2015
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02356224
Brief Title
The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers
Acronym
SHR3824
Official Title
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Single Dose of SHR3824 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
SHR3824 Type 2 diabetes mellitus SGLT2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
SHR3824 2.5 mg/day or placebo.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 7
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SHR3824
Other Intervention Name(s)
Henagliflozin
Intervention Description
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
Primary Outcome Measure Information:
Title
Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.
Time Frame
24h after dosing
Title
SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.
Time Frame
Up to 72h after dosing
Secondary Outcome Measure Information:
Title
The number of patients with adverse events as a measure of safety and tolerability
Time Frame
up to day 72h after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Xuhui Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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