Gout Patients
Conditions
Keywords
Hyperuricemia, Gout, URAT1
Brief summary
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.
Interventions
DRUGGroup 1: AR882 Alone and in Combination with Febuxostat (FBX)
AR882 + Febuxostat, AR882 alone, Febuxostat alone
DRUGGroup 2: AR882 Alone and in Combination with Allopurinol (ALLO)
AR882 + Allopurinol, AR882 alone, Allopurinol alone
Sponsors
Arthrosi Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD profile of AR882 administered alone or in combination with febuxostat | 22 Days | Profile from serum uric acid concentration over time |
| PD profile of AR882 administered alone or in combination with allopurinol | 22 Days | Profile from serum uric acid concentration over time. |
| Serum uric acid (sUA) response rate | 22 Days | sUA response rate to achieve sUA \<6, \<5, \<4, and \<3 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) for AR882 | 22 Days | Profile from plasma in terms of Cmax for AR882 |
| Apparent terminal half-life (t1/2) for AR882 | 22 Days | Profile from plasma in terms of t1/2 for AR882 |
| Amount excreted (Ae) into urine for AR882 | 22 Days | Profile from urine in terms of Ae for AR882 |
| Renal clearance (CLr) for AR882 | 22 Days | Profile from urine in terms of CLr for AR882 |
| AUC for plasma for febuxostat | 22 Days | Profile from plasma in terms of AUC for febuxostat |
| Tmax for febuxostat | 22 Days | Profile from plasma in terms of Tmax for febuxostat |
| Cmax for febuxostat | 22 Days | Profile from plasma in terms of Cmax for febuxostat |
| t1/2 for febuxostat | 22 Days | Profile from plasma in terms of t1/2 for febuxostat |
| AUC for plasma allopurinol/oxypurinol | 22 Days | Profile from plasma in terms of AUC for allopurinol/oxypurinol |
| Area under the curve (AUC) for plasma AR882 | 22 Days | Profile from plasma in terms of AUC for AR882 |
| Tmax for colchicine | 22 Days | Profile from plasma in terms of Tmax for colchicine |
| Tmax for allopurinol/oxypurinol | 22 Days | Profile from plasma in terms of Tmax for allopurinol/oxypurinol |
| Cmax for allopurinol/oxypurinol | 22 Days | Profile from plasma in terms of Cmax for allopurinol/oxypurinol |
| t1/2 for for allopurinol/oxypurinol | 22 Days | Profile from plasma in terms of t1/2 for allopurinol/oxypurinol |
| Ae in urine for allopurinol/oxypurinol | 22 Days | Profile from urine in terms of Ae for allopurinol/oxypurinol |
| Cmax for colchicine | 22 Days | Profile from plasma in terms of Cmax for colchicine |
| t1/2 for for colchicine | 22 Days | Profile from plasma in terms of t1/2 for colchicine |
| Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs | 28 Days | — |
| AUC for plasma for colchicine | 22 Days | Profile from plasma in terms of AUC for colchicine |
| CLr for allopurinol/oxypurinol | 22 Days | Profile from urine in terms of CLr for allopurinol/oxypurinol |
| Time to maximum plasma concentration (Tmax) for AR882 | 22 Days | Profile from plasma in terms of Tmax for AR882 |
Countries
New Zealand
Outcome results
None listed