This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Unnamed facility
Overland Park, Kansas, United States
Maximum Observed Plasma Concentration (Cmax)
Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time frame: 22 days
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time frame: 22 days
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time frame: 22 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time frame: 22 days
Apparent Terminal Half-life (t1/2)
t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time frame: 22 days
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170
Time frame: 22 days
Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)
CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Time frame: 22 days
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine
Time frame: 22 days
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Maximum Observed Plasma Concentration (Cmax)
Cmax of RDEA3170 Alone and In Combination with Allopurinol
Time frame: 22 days
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Time frame: 22 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last of RDEA3170 Alone and In Combination with Allopurinol
Time frame: 22 days
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Time frame: 22 days
Incidence of Treatment-Emergent Adverse Events
Time frame: 22 days