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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR882/FBX | Experimental |
| |
| AR882/ALLO | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: AR882 Alone and in Combination with Febuxostat (FBX) | Drug | AR882 + Febuxostat, AR882 alone, Febuxostat alone |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Wynne, MBChB, Grad Dip Pharm Med | Christchurch Clinical Studies Trust Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch Clinical Studies Trust, Ltd (CCST) | Christchurch | New Zealand |
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| Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) | Drug | AR882 + Allopurinol, AR882 alone, Allopurinol alone |
|
|
| 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 |
| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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