To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

Study Overview
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Brief Summary
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A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout

Official Title
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A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout

Conditions
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Gout

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a body mass index ≥18.0 and ≤32 kg/m2; Screening sUA value ≥480μmol/L; 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； History of xanthinuria； Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood ALT or AST > 1.5 x ULN Unstable angina, history of symptomatic arrhythmia, or heart failure HbAlc>8% eGFR<60ml/min/1.73m2 Investigational drug within 3 months of study dosing

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 |
| --- | --- |
| Other: Cohort 1<br>Colchicine 0.5 mg Oral Tablet Day-7 Day25 qd, Febuxostat 40 mg Oral Tablet Day1 and Day14 qd, XNW3009 0.5 mg Oral Tablet Day8 Day21 qd. Interventions: Drug: Colchicine Drug: Febuxostat Drug: XNW3009 | Drug: Colchicine<br>* Colchicine0.5 mg Oral Tablet Day-7 Day25 qd；Febuxostat 40 mg Oral Tablet Day1 and Day14 qd；XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd<br>* Other names: Febuxostat、XNW3009;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed maximum concentration at steady state (Cmax,ss) | To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout | 100 days | 
| Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) | To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Serum Concentration (Tmax) | To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout | 100 days | 
| Mean Terminal Phase Half-life (t1/2) | To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients | 100 days | 
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. | 100 days | 
| Serum or urine Uric Acid Level | Change in Serum or urine Uric Acid Level | 100 days | 
| Serum or urine Creatinine | Change in Serum or urine Creatinine | 100 days | 
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Investigator judged clinical significance of laboratory test abnormalities. | 100 days |