Hyperuricemia
Conditions
Brief summary
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
Interventions
DRUGRDEA806
Uricosuric agent for the treatment of gout
DRUGPlacebo
Matching Placebo.
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL. * Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout. * Patient is willing and able to give informed consent and adhere to visit/protocol schedules * All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap).
Exclusion criteria
* Consumes more than 14 drinks of alcohol per week. * History or suspicion of drug abuse. * History of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction. * Diabetes Mellitus requiring treatment * Confirmed or suspected HIV-1 infection. * Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia. * Uncontrolled hypertension. * Inadequate renal function. * Hemoglobin \< 8 g/dL (males) or \< 7 g/dL (females). * ALT, AST , or GGT 2 x ULN * Active peptic ulcer disease. * Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim. * Pregnant or breast feeding. * Use of an investigational drug within 4 weeks prior to study drug administration. * Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations. * Any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study. * History of cardiac abnormalities including abnormal and clinically relevant ECG changes. * Conditions predisposing to QT prolongation. * Any use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day 1. * Subjects with a QTcF interval \>450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit. | 4 weeks |
| To evaluate the absolute and percent reduction from baseline in sUA levels | 4 weeks |
| To evaluate percent change in 24-hour urine uric acid level | 4 weeks |
Countries
Canada
Outcome results
None listed