RDEA3170 and Allopurinol Combination Study in Gout Subjects
- Registration Number
- NCT02279641
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
- Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria
- Subject is unable to take colchicine for gout flare prophylaxis.
- Subject has a history or suspicion of kidney stones.
- Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
- Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
- Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
- Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequence A RDEA3170 10 mg RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd Sequence A allopurinol 300 mg RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd Sequence B RDEA3170 10 mg allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd Sequence B allopurinol 300 mg allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
- Primary Outcome Measures
Name Time Method Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24) 22 days CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Maximum Observed Plasma Concentration (Cmax) 22 days Cmax of RDEA3170 Alone and In Combination with Allopurinol
Time of Occurrence of Maximum Observed Concentration (Tmax) 22 days Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) 22 days AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) 22 days AUC last of RDEA3170 Alone and In Combination with Allopurinol
Apparent Terminal Half-life (t1/2) 22 days t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24) 22 days Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol
Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine 22 days
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events 22 days