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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
110
Research Site
Fukuoka, Japan
Change in Serum uric acid level
% change per treatment will be compared.
Time frame: baseline and day 7 on each treatment
Change in Urinary excretion of uric acid
Timed urinary uric acid excretion per treatment will be compared
Time frame: baseline and day 7 on each treatment
Renal clearance of uric acid
Renal clearance of uric acid will be calculated.
Time frame: baseline and day 7 on each treatment
Fractional excretion of uric acid
Fractional excretion and renal clearance of uric acid will be calculated.
Time frame: baseline and day 7 on each treatment
Maximum plasma concentration (Cmax)
To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment
Time to reach maximum concentration (tmax)
To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment
Area under the concentration-time curve (AUC)
To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment
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Half life (t1/2)
To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment
Incidence of adverse events
To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Time frame: Day 1 and Day 7 on each treatment
Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters
To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Time frame: Day 1 and Day 8 on each treatment
Changes in vital signs and physical examination findings
To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Time frame: Day 1 and Day 8 on each treatment
Incidence of adverse events
To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Time frame: Day 42 of the study as follow up
Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters
To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Time frame: Day 42 of the study as follow up
Changes in vital signs and physical examination findings
To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170
Time frame: Day 42 of the study as follow up