Back to resultsThe Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
Primary Purpose
Gout
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Colchicine
Febuxostat
SHR4640
Sponsored by
About this trial
This is an interventional treatment trial for Gout focused on measuring SHR4640 Febuxostat Colchicine pharmacodynamics
Eligibility Criteria
Inclusion Criteria:
- Subject has a body mass index ≥18.5 and ≤30 kg/m2;
- Screening sUA value ≥8mg/dl;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Exclusion Criteria:
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- sCr>ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy within 5 years；
- History of xanthinuria；
- Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。
Sites / Locations
- The First Affiliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohort 1
Arm Description
Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd.
Outcomes
Primary Outcome Measures
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
PK profile
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
PK profile
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
PK profile
Secondary Outcome Measures
Incidence of Adverse events
Safety issue
Changes in Laboratory Values
Safety issue
Changes in Electrocardiogram
Safety issue
Changes in Vital Signs Parameters
Safety issue
Full Information
NCT ID
NCT03131583
First Posted
February 27, 2017
Last Updated
August 6, 2019
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03131583
Brief Title
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
Official Title
A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
SHR4640 Febuxostat Colchicine pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Day-14~Day16 qd
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Intervention Description
Day1 and Day8 qd
Intervention Type
Drug
Intervention Name(s)
SHR4640
Intervention Description
Day3~Day8 qd
Primary Outcome Measure Information:
Title
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
Description
PK profile
Time Frame
Clinical significant changes from baseline up to Day 8
Title
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
Description
PK profile
Time Frame
Clinical significant changes from baseline up to Day 8
Title
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
Description
PK profile
Time Frame
Clinical significant changes from baseline up to Day 8
Secondary Outcome Measure Information:
Title
Incidence of Adverse events
Description
Safety issue
Time Frame
Clinical significant changes from Day-14 up to Day 16
Title
Changes in Laboratory Values
Description
Safety issue
Time Frame
Clinical significant changes from Day-14 up to Day 16
Title
Changes in Electrocardiogram
Description
Safety issue
Time Frame
Clinical significant changes from Day-14 up to Day 16
Title
Changes in Vital Signs Parameters
Description
Safety issue
Time Frame
Clinical significant changes from Day-14 up to Day 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has a body mass index ≥18.5 and ≤30 kg/m2;
Screening sUA value ≥8mg/dl;
Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Exclusion Criteria:
Subject known or suspected of being sensitive to the study drugs or its ingredient；
sCr>ULN;
History of kidney stones or screening kidney stones by B-ultrasound；
History of malignancy within 5 years；
History of xanthinuria；
Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
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