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Multiple Dose Study of SHR4640 in Healthy Subjects

Primary Purpose

Gout; Hyperuricemia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR4640
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 Gout; Hyperuricemia focused on measuring SHR4640 pharmacokinetics pharmacodynamics

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age between 18 and 55, male;
  2. Body weight≥50, BMI:19-25kg/m2;

3.4 mg/dL≤Screening serum urate level≤7 mg/dL;

4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.

Exclusion Criteria:

  1. Serum creatinine>upper limits of normal(ULN);
  2. Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;
  3. History of hyperuricemia or gout;
  4. History or suspicion of kidney stones;
  5. Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.

Sites / Locations

  • The South West Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

1mg SHR4640 or placebo

2.5mg SHR4640 or placebo

5mg SHR4640 or placebo

10mg SHR4640 or placebo

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Peak Plasma Concentration(Cmax)(of single dose and at stable status)
Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)
Half-time(T1/2)(of single dose and at stable status)
Time to the peak plasma concentration(Tmax)(of single dose and at stable status)
Changes in serum uric acid concentration from baseline
Changes in urinary uric acid excretion from baseline

Full Information

First Posted
September 1, 2016
Last Updated
March 29, 2017
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02890966
Brief Title
Multiple Dose Study of SHR4640 in Healthy Subjects
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout; Hyperuricemia
Keywords
SHR4640 pharmacokinetics pharmacodynamics

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
1mg SHR4640 or placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
2.5mg SHR4640 or placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
5mg SHR4640 or placebo
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
10mg SHR4640 or placebo
Intervention Type
Drug
Intervention Name(s)
SHR4640
Intervention Description
Day1~Day7:oral administration
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Day1~Day7:oral administration
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
Clinical significant changes from baseline up to Day 10
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration(Cmax)(of single dose and at stable status)
Time Frame
Up to Day 10
Title
Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)
Time Frame
Up to Day 10
Title
Half-time(T1/2)(of single dose and at stable status)
Time Frame
Up to Day 10
Title
Time to the peak plasma concentration(Tmax)(of single dose and at stable status)
Time Frame
Up to Day 10
Title
Changes in serum uric acid concentration from baseline
Time Frame
Up to Day 10
Title
Changes in urinary uric acid excretion from baseline
Time Frame
Up to Day 10

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 55, male; Body weight≥50, BMI:19-25kg/m2; 3.4 mg/dL≤Screening serum urate level≤7 mg/dL; 4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening. Exclusion Criteria: Serum creatinine>upper limits of normal(ULN); Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN; History of hyperuricemia or gout; History or suspicion of kidney stones; Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.
Facility Information:
Facility Name
The South West Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Multiple Dose Study of SHR4640 in Healthy Subjects

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