- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03131583
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
August 6, 2019 updated by: Jiangsu HengRui Medicine Co., Ltd.
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
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
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
-
-
Jiangsu
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Suzhou, Jiangsu, China, 215006
- The First Affiliated Hospital of Soochow University
-
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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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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。
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
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.
|
Day-14~Day16 qd
Day1 and Day8 qd
Day3~Day8 qd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
Time Frame: Clinical significant changes from baseline up to Day 8
|
PK profile
|
Clinical significant changes from baseline up to Day 8
|
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
Time Frame: Clinical significant changes from baseline up to Day 8
|
PK profile
|
Clinical significant changes from baseline up to Day 8
|
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
Time Frame: Clinical significant changes from baseline up to Day 8
|
PK profile
|
Clinical significant changes from baseline up to Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse events
Time Frame: Clinical significant changes from Day-14 up to Day 16
|
Safety issue
|
Clinical significant changes from Day-14 up to Day 16
|
Changes in Laboratory Values
Time Frame: Clinical significant changes from Day-14 up to Day 16
|
Safety issue
|
Clinical significant changes from Day-14 up to Day 16
|
Changes in Electrocardiogram
Time Frame: Clinical significant changes from Day-14 up to Day 16
|
Safety issue
|
Clinical significant changes from Day-14 up to Day 16
|
Changes in Vital Signs Parameters
Time Frame: Clinical significant changes from Day-14 up to Day 16
|
Safety issue
|
Clinical significant changes from Day-14 up to Day 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
February 17, 2017
Primary Completion (Actual)
January 29, 2018
Study Completion (Actual)
January 29, 2018
Study Registration Dates
First Submitted
February 27, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 27, 2017
Study Record Updates
Last Update Posted (Actual)
August 8, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Metabolism, Inborn Errors
- Crystal Arthropathies
- Purine-Pyrimidine Metabolism, Inborn Errors
- Gout
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gout Suppressants
- Colchicine
- Febuxostat
Other Study ID Numbers
- SHR4640-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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