Gout MedDRA version: 13.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: RDEA594, 100 mg
Product Code: RDEA594
Pharmaceutical Form: Capsule, hard
CAS Number: 1151516-14-1
Current Sponsor code: RDEA594 sodium
Other descriptive name: lesinurad sodium
Concentrat
Sponsors
Ardea Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject is male or a post-menopausal or surgically sterile female. (Post-menopausal is generally defined as a period of twelve (12) consecutive months of amenorrhoea. In women under 55 years of age whose menopausal status is in question, a follicle-stimulating hormone (FSH) level of >40 mIU/ml or an oestrogen deficiency of =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.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). 2.Subject with a history or suspicion of drug abuse. 3.Subject with a history of documented or suspected kidney stones. 4.Subject has rheumatoid arthritis or other autoimmune disease requiring treatment. 5.Subject with documented or suspicion of HIV infection. 6.Subject with a positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg). 7.Subject with a history of malignancy within 5 years prior to the first dose of study medication, other than non-melanomatous skin cancer or cervical dysplasia. 8.Subject with a history of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate 120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years. 9.Subject with any condition predisposing to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV). 10.Subject with any use of concomitant medications that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 1). 11.Subject with a QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 1). 12.Subject with uncontrolled hypertension (above 150/95). 13.Subject with inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance 3 x ULN. 17.Subject with active peptic ulcer disease requiring treatment. 18.Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction. 19.Subject requires therapy with any other urate-lowering medication, other than the study medications. 20.Subject requires long-term use of salicylates above 100 mg per day; thiazide diuretics (except low-dose hydrochlorothiazide); losartan; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim. 21.Subject taking medications known as enzyme inducers. 22.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. 23.Subject with an acute gout flare (exclusive of chronic synovitis/ arthritis) during the Screening-Period that has not resolved one week prior to the Baseline Visit (Day 0). 24.Subject is pregnant or breast feeding. 25.Subject who has received an investigational medication within 4 weeks prior to the screening visit for this study. 26.Subject who previously participated in a clinical study involving RDEA806 or RDEA594. 27.Subject with known hypersen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the percent reduction from baseline in serum urate (sUA) levels following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.;Primary end point(s): To compare the percent reduction from baseline in serum urate (sUA) levels following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.;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 study visit by treatment group in all subjects and in subjects who have an sUA greater than or equal to 6 mg/dL at the baseline visit. •To evaluate the absolute and percent reduction from baseline in sUA levels at each visit. •To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28. •To evaluate the incidence of gout flares. •To evaluate the safety and tolerability of RDEA594 in combination with allopurinol in subjects with gout. •To compare the multiple-dose pharmacokinetics (PK) of allopurinol and oxypurinol in the absence versus presence of RDEA594 co-administration. •To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL and <5.0 mg/dL in the double-blind and Open-Label Extension Periods.;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -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 study visit by treatment group in all subjects and in subjects who have an sUA = 6 mg/dL at the baseline visit. -To evaluate the absolute and percent reduction from baseline in sUA levels at each visit. -To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28. -To evaluate the incidence of gout flares. -To evaluate the safety and tolerability of RDEA594 in combination with allopurinol in subjects with gout. -To compare the multiple-dose pharmacokinetics (PK) of allopurinol and oxypurinol in the absence versus presence of RDEA594 co-administration. -To evaluate the proportion of subjects whose sUA level decreases to or is maintained at < 6.0 mg/dL and < 5.0 mg/dL in the Double-Blind and Open-Label Extension Periods.;Timepoint(s) of evaluation of this end point: 28 days and through extension | — |
Countries
Poland, Spain, United Kingdom
Contacts
Public ContactProject Manager of Trial
Pharm-Olam International
Outcome results
None listed