Gout MedDRA version: 9.1 Level: LLT Classification code 10018627 Term: Gout
Conditions
Interventions
Product Name: RDEA806 Immediate Release Capsule
Pharmaceutical Form: Capsule, hard
CAS Number: 878670-63-4
Current Sponsor code: RDEA806
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Ardea Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female outpatients of either gender, age 18 - 75 yrs of age. •Patient is hyperuricemic: screening serum uric acid =8 mg/dL. •Patient meets one or more of the 1977 ACR criteria for the diagnosis of gout. •Patient is willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed, including Washout). •All female subjects of child-bearing potential must agree to use a double barrier method of birth control (e.g. condom, diaphragm or cap). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. •Confirmed or suspected HIV-1 infection •Malignancy, except treated non-melanomatous skin cancer and cervical dsyplasia •Significant cardiac dysfunction including congestive heart failure (NYCA Class III or IV); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormailities unless corrected with a cardiac pacemaker; prolonged QTC (> 460 msec). •Uncontrolled hypertension (above 150/95). •Inadequate renal function (serum creatinine >1.5 mg/dL or creatinine clearance 450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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. ;Secondary Objective: •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. •To evaluate the absolute and percent reduction from baseline in sUA levels, at each visit. •To evaluate the maximum percent reduction in sUA levels, from baseline during the entire treatment period. •To evaluate percent change in 24-hour urine uric acid level from baseline to Week 4. •To evaluate the percent reduction in sUA levels from baseline, summarized by baseline serum creatinine levels, baseline 24 hour urine uric acid excretion and baseline tophus presence or absence. •To evaluate the safety and tolerability of RDEA806 in subjects with gout. •To evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 and its metabolites in subjects with gout. ;Primary end point(s): The primary efficacy endpoint will be serum uric acid (sUA) level <6.0 mg/dl following 4 weeks of RDEA806 using intent-to-treat (IIT) analysis. | — |
Countries
Belgium, Spain
Outcome results
None listed