The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

Study Overview
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Brief Summary
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The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.

Official Title
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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

Conditions
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Gout

Intervention / Treatment
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* Drug: Colchicine
* Drug: Febuxostat
* Drug: SHR4640


Participation Criteria
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Eligibility Criteria
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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。

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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. | Drug: Colchicine<br>* Day-14 Day16 qd<br>Drug: Febuxostat<br>* Day1 and Day8 qd<br>Drug: SHR4640<br>* Day3 Day8 qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma | PK profile | Clinical significant changes from baseline up to Day 8 | 
| Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma | PK profile | Clinical significant changes from baseline up to Day 8 | 
| Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma | PK profile | Clinical significant changes from baseline up to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events | Safety issue | Clinical significant changes from Day-14 up to Day 16 | 
| Changes in Laboratory Values | Safety issue | Clinical significant changes from Day-14 up to Day 16 | 
| Changes in Electrocardiogram | Safety issue | Clinical significant changes from Day-14 up to Day 16 | 
| Changes in Vital Signs Parameters | Safety issue | Clinical significant changes from Day-14 up to Day 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR4640 Febuxostat Colchicine pharmacodynamics