Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients with Gout

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

1.Subject is male or post-menopausal or surgically sterile female.
2.Subject is 18 - 75 years of age.
3.Subject is hyperuricemic (i.e., screening sUA ?8 mg/dL).
4.Subject meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout. 5.Subject 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).
6. Subjects entering the optional Extension Period must have successfully completed the Double-Blind Treatment Period and Follow-up Period within approximately 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
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

1. Subject is classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
2. Subject who consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
3. Subject with a history or suspicion of drug abuse.
4. Subject with a documented history of or suspicion of kidney stones.
5. Subject with a history of rheumatoid arthritis or other autoimmune disease.
6. Subject with confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
7. Subject with a positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
8. Subjects with a history of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
9. Subject with a history of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate <45 bpm), complete left bundle branch block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration >120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequentpalpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in an otherwise healthy individual between the ages of 1 and 30 years.
10. Subject with any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
11. Subject with any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0).
12. Subject with a QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0).
13. Subject with uncontrolled hypertension (above 150/95).
14. Subject with inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by Cockroft-Gault formula)].
15. Subject with hemoglobin < 10 g/dL (males) or < 9 g/dL (females).
16. Subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN).
17. Subject with gamma glutamyl transferase (GGT) > 3 x ULN.
18. Subject with active peptic ulcer disease requiring treatment.
19. Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
20. Subject requires therapy with any other urate-lowering medication, other than the study medication.
21. Subject requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim.
22. Subjects taking medications known as enzyme inducers (see section 3.7 for listing).
23. Subject reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing, due to potential interactions with colchicine.
24. Subject with an acute gout flare (exclusive of chronic synovitis/ arthritis) at Screening or during the Wash-out Period that has not resolved at least one week prior to the Baseline visit.
25. Subject is a female of childbearing potential.
26. Subject who has received an investigational medication within 4 weeks prior to study medication administration.
27. Subject who previously participated in a clinical study involving RDEA806 or RDEA594.
28. Subject with a known hypersensi

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after following 4 weeks of dosig by treatment group.;Secondary Objective: To evaluate the proportion of subjects whose sUA levels are <6.0, <5.0 and <4.0 mg/dL at each weekly study visit during the Double-Blind Period.<br>To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.<br>To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.<br>To evaluate the incidence of gout flares.<br>To evaluate the safety and tolerability of RDEA594 in subjects with gout.<br>To evaluate the propotion of subjects whose sUA level decreases to or is maintained at < 6.0 mg/dL in the Open-Lable Extension Period.;Primary end point(s): To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL following 4 weeks of dosing by treatment group.

Secondary Outcome Measures

Name	Time	Method

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