The study was conducted in normal healthy volunteers with serum uric acid above 5mg/dl. The results of this study demonstrated that single doses of up to 600mg of RDEA594 were well tolerated, with linear increases in drug levels observed throughout the dose range investigated, and with up to an 11 hour elimination half-life. There was also a dose related decrease in serum uric acid in the first 24 hours after dosing.
Overall reductions compared to placebo of up to 30% in serum uric acid over the first 24 hours were observed with RDEA594, which is about twice that observed in prior studies with a single 800mg dose of RDEA594’s prodrug, RDEA806, and is favorable to published results for benzbromarone in normal healthy volunteers, a drug previously used to treat gout patients that is believed to work via a similar mechanism of action.
Ardea has initiated a multiple ascending dose (MAD) study of RDEA594 in healthy volunteers to investigate the safety, pharmacokinetics, and pharmacodynamics of RDEA594 administered once daily for 10 days.
Barry Quart, CEO of Ardea Biosciences, said: The results from the single ascending dose study demonstrate the tolerability and potent activity of RDEA594 in reducing serum uric acid. We have continued our expedited development of this compound with the initiation late last year of the MAD study, which is designed to identify doses for the planned Phase II dose-response study in gout patients later this year.