Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients

Study Overview
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Brief Summary
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The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.

Official Title
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A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients

Conditions
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Gout Patients

Intervention / Treatment
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* Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
* Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: History of gout sUA > 7 mg/dL Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2 Key Exclusion Criteria: Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin History of cardiac abnormalities Active peptic ulcer disease or active liver disease History of kidney stones Allergy or intolerance to colchicine, febuxostat, and allopurinol

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR882/FBX<br> | Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)<br>* AR882 + Febuxostat, AR882 alone, Febuxostat alone<br>* Other names: Febuxostat (Adenuric®, Uloric®);|
| Experimental: AR882/ALLO<br> | Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)<br>* AR882 + Allopurinol, AR882 alone, Allopurinol alone<br>* Other names: Allopurinol (Allosig®, Progout®, Zyloprim®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD profile of AR882 administered alone or in combination with febuxostat | Profile from serum uric acid concentration over time | 22 Days | 
| PD profile of AR882 administered alone or in combination with allopurinol | Profile from serum uric acid concentration over time. | 22 Days | 
| Serum uric acid (sUA) response rate | sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL | 22 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) for plasma AR882 | Profile from plasma in terms of AUC for AR882 | 22 Days | 
| Time to maximum plasma concentration (Tmax) for AR882 | Profile from plasma in terms of Tmax for AR882 | 22 Days | 
| Maximum plasma concentration (Cmax) for AR882 | Profile from plasma in terms of Cmax for AR882 | 22 Days | 
| Apparent terminal half-life (t1/2) for AR882 | Profile from plasma in terms of t1/2 for AR882 | 22 Days | 
| Amount excreted (Ae) into urine for AR882 | Profile from urine in terms of Ae for AR882 | 22 Days | 
| Renal clearance (CLr) for AR882 | Profile from urine in terms of CLr for AR882 | 22 Days | 
| AUC for plasma for febuxostat | Profile from plasma in terms of AUC for febuxostat | 22 Days | 
| Tmax for febuxostat | Profile from plasma in terms of Tmax for febuxostat | 22 Days | 
| Cmax for febuxostat | Profile from plasma in terms of Cmax for febuxostat | 22 Days | 
| t1/2 for febuxostat | Profile from plasma in terms of t1/2 for febuxostat | 22 Days | 
| AUC for plasma allopurinol/oxypurinol | Profile from plasma in terms of AUC for allopurinol/oxypurinol | 22 Days | 
| Tmax for allopurinol/oxypurinol | Profile from plasma in terms of Tmax for allopurinol/oxypurinol | 22 Days | 
| Cmax for allopurinol/oxypurinol | Profile from plasma in terms of Cmax for allopurinol/oxypurinol | 22 Days | 
| t1/2 for for allopurinol/oxypurinol | Profile from plasma in terms of t1/2 for allopurinol/oxypurinol | 22 Days | 
| Ae in urine for allopurinol/oxypurinol | Profile from urine in terms of Ae for allopurinol/oxypurinol | 22 Days | 
| CLr for allopurinol/oxypurinol | Profile from urine in terms of CLr for allopurinol/oxypurinol | 22 Days | 
| AUC for plasma for colchicine | Profile from plasma in terms of AUC for colchicine | 22 Days | 
| Tmax for colchicine | Profile from plasma in terms of Tmax for colchicine | 22 Days | 
| Cmax for colchicine | Profile from plasma in terms of Cmax for colchicine | 22 Days | 
| t1/2 for for colchicine | Profile from plasma in terms of t1/2 for colchicine | 22 Days | 
| Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs |  | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperuricemia, Gout, URAT1