A Single & Multiple Ascending Dose Study for Safety, PK, PD and FE

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Food Effect of Single and Multiple Rising Doses of RDEA3170, a URAT1 Inhibitor in Healthy Adult Male Volunteers

• IRAS ID

  84532

• Sponsor organisation

  Ardea Biosciences, Inc.

• Eudract number

  2011-002498-47

• Research summary

  Ardea Biosciences is developing RDEA3170 as a potential treatment for the management of gout. Gout is a medical condition that results from deposition of urate crystals in tissues of the body (mainly joints and kidney) resulting in repeated episodes of joint inflammation (arthritis), impaired kidney function, and kidney stones. Gout is caused by high levels of uric acid in the blood which is often related to an inherited abnormality in the body's ability to process urate, but may also be exacerbated by a high intake of certain foods. This study will be conducted at a single centre with a plan to enrol up to 136 healthy adult male subjects. The study is divided into 2 segments. Segment A: will investigate the safety, tolerability, pharmacokinetics (PK; levels of drug in the blood), and food effect of single doses of RDEA3170. Eight subjects in each of the eleven groups will receive single doses of RDEA3170 or placebo. Segment B: will investigate the safety, tolerability and PK of multiple oral doses of RDEA3170. Twelve healthy subjects in each of the 4 groups will receive 10 days of multiple oral dosing of RDEA3170 or placebo.Additionally, this study will examine the ability of the study drug to enhance the excretion of uric acid in urine. All subjects will be healthy male volunteers aged between 18 and 45 years. Each subject will take part in one treatment period involving single or multiple oral doses of RDEA3170 or placebo. In both segments following review of safety and PK data from earlier groups, it is intended that the dose level will increase between each group except for the food effect group where the dose will be identical to a previously evaluated dose level that has shown to be safe and well-tolerated.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0115

• Date of REC Opinion

  4 Aug 2011

• REC opinion

  Further Information Favourable Opinion