Clinical Trial: A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients

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

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

Brief Summary: The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

  • Change in Serum uric acid level [ Time Frame: baseline and day 7 on each treatment ]
    % change per treatment will be compared.
  • Change in Urinary excretion of uric acid [ Time Frame: baseline and day 7 on each treatment ]
    Timed urinary uric acid excretion per treatment will be compared
  • Renal clearance of uric acid [ Time Frame: baseline and day 7 on each treatment ]
    Renal clearance of uric acid will be calculated.
  • Fractional excretion of uric acid [ Time Frame: baseline and day 7 on each treatment ]
    Fractional excretion and renal clearance of uric acid will be calculated.


Original Primary Outcome:

  • Change in Serum uric acid level [ Time Frame: baseline and day 1 on each treatment ]
    % change per treatment will be compared.
  • Change in Urinary excretion of uric acid [ Time Frame: baseline and day 1 on each treatment ]
    Timed urinary uric acid excretion per treatment will be compared


Current Secondary Outcome:

  • Maximum plasma concentration (Cmax) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
  • Time to reach maximum concentration (tmax) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
  • Area under the concentration-time curve (AUC) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
  • Half life (t1/2) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
  • Incidence of adverse events [ Time Frame: Day 1 and Day 7 on each treatment ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters [ Time Frame: Day 1 and Day 8 on each treatment ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in vital signs and physical examination findings [ Time Frame: Day 1 and Day 8 on each treatment ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Incidence of adverse events [ Time Frame: Day 42 of the study as follow up ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters [ Time Frame: Day 42 of the study as follow up ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in vital signs and physical examination findings [ Time Frame: Day 42 of the study as follow up ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170


Original Secondary Outcome:

  • Maximum plasma concentration (Cmax) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess the multiple-dose PK of RDEA3170 administered in combination with febuxostat and the multiple-dose PK of RDEA3170 administered alone and of febuxostat administered alone, respectively
  • Time to reach maximum concentration (tmax) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess the multiple-dose PK of RDEA3170 administered in combination with febuxostat and the multiple-dose PK of RDEA3170 administered alone and of febuxostat administered alone, and respectively
  • Area under the concentration-time curve (AUC) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess the multiple-dose PK of RDEA3170 administered in combination with febuxostat and the multiple-dose PK of RDEA3170 administered alone and of febuxostat administered alone, and respectively
  • Half life (t1/2) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post‐dose on each treatment ]
    To assess the multiple-dose PK of RDEA3170 administered in combination with febuxostat and the multiple-dose PK of RDEA3170 administered alone and of febuxostat administered alone, and respectively
  • Incidence of adverse events [ Time Frame: Day 1-Day 7 on each treatment ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters [ Time Frame: Day 1 and Day 8 on each treatment ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in vital signs and physical examination findings [ Time Frame: Day 1 and Day 8 on each treatment ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Incidence of adverse events [ Time Frame: Day 42 of the study as follow up ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters [ Time Frame: Day 42 of the study as follow up ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
  • Changes in vital signs and physical examination findings [ Time Frame: Day 42 of the study as follow up ]
    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170


Information By: AstraZeneca

Dates:
Date Received: December 9, 2014
Date Started: December 2014
Date Completion:
Last Updated: June 11, 2015
Last Verified: June 2015