This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Unnamed facility
Anaheim, California, United States
Unnamed facility
Glendale, California, United States
Unnamed facility
South Miami, Florida, United States
Unnamed facility
Overland Park, Kansas, United States
Serum Urate Maximum Percentage (%) Change (Emax, CB)
Maximum observed percentage (%) change from baseline in serum urate concentrations.
Time frame: 28 days
Urine Uric Acid % Change (0-24h) (Aeur, CB)
Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Time frame: 28 days
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Percentage (%) change from baseline in renal clearance of uric acid.
Time frame: 28 days
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Percentage (%) change from baseline in fractional excretion of uric acid.
Time frame: 28 days
Maximum Observed Plasma Concentration (Cmax)
Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time frame: Days 7 to 28
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time frame: Days 7 to 28
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time frame: Days 7 to 28
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
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Unnamed facility
Overland Park, Kansas, United States
Unnamed facility
Dallas, Texas, United States
AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time frame: Days 7 to 28
Apparent Terminal Half-life (t1/2)
t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Time frame: Days 7 to 28
Incidence of Treatment-Emergent Adverse Events
Time frame: 10 weeks