Clinical Trial: Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adu

Brief Summary: This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.

Detailed Summary:
Sponsor: Ardea Biosciences, Inc.

Current Primary Outcome: PD profile of multiple-dose RDEA3170 administered in combination with allopurinol [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 ]

Serial serum and urine samples measured at various timepoints

PD endpoints in terms of maximum time-matched percentage change from baseline (Study Day -1) in serum urate, serum urate concentration, urine uric acid excretion amount, time-adjusted urine uric acid excretion rate, renal clearance of uric acid, and fractional excretion of uric acid.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PK profile of multiple-dose RDEA3170 administered with allopurinol from plasma [ Time Frame: Day 7, 14, 21, 28 and 35 ]

    Serial plasma samples measured at various timepoints

    PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); apparent terminal half-life (t1/2)

  • Incidence of Adverse Events [ Time Frame: 11 weeks ]
    Changes in Laboratory, Electrocardiogram and Vital Signs Parameters


Original Secondary Outcome: Same as current

Information By: Ardea Biosciences, Inc.

Dates:
Date Received: July 13, 2015
Date Started: July 2015
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016