RDEA594: Additional Phase I data

Data from the second dosing cohort of a placebo-controlled Phase I trial in 18 healthy volunteers showed that 400 mg RDEA594 plus 40 mg febuxostat led to a mean reduction from baseline in serum urate concentration of about 70%. RDEA594 and febuxostat alone reduced mean serum urate concentrations by 49% and 45%, respectively. The combination was well tolerated. Subjects received 400 mg once-daily RDEA594, 40 mg once-daily febuxostat or placebo alone for the first week, combination therapy for the second week, and the single agent they did not receive in the first week or placebo for the third week. Ardea previously reported that 200 mg RDEA594 plus 40 mg febuxostat led to a mean reduction from baseline in serum urate concentration of about 60% in 18 healthy volunteers (see BioCentury, Dec. 7, 2009). ...