This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
21
RDEA3170 10 mg once daily (qd)
Febuxostat 40 mg qd
placebo qd
Unnamed facility
Kalamazoo, Michigan, United States
PK profile of RDEA3170 from plasma and urine and febuxostat from plasma
Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance
Time frame: Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only)
PD profile of RDEA3170 and febuxostat alone and in combination
Profile from serum and urine in terms of sUA concentration, renal clearance of uric acid, urine uric acid excretion amounts, and fractional excretion of uric acid. sUA: serum urate
Time frame: Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only)
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 8 weeks
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