RDEA3170 PK/PD Study
- Conditions
- Gout
- Interventions
- Drug: RDEA3170 4.5 mgDrug: RDEA3170 6 mgDrug: RDEA3170 12 mg
- Registration Number
- NCT02608710
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level 4 to 7 mg/dL
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
- Subject has clinically unacceptable physical examination, per the Investigator's judgment.
- Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
- Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
- Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
- Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
- Subject has a history of cardiac abnormalities
- Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Dose RDEA3170 4.5 mg Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. Single Dose RDEA3170 6 mg Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. Single Dose RDEA3170 12 mg Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. Multiple Dose RDEA3170 12 mg RDEA3170 12 mg once daily (qd) Single Dose Food Effect RDEA3170 6 mg Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.
- Primary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Days -1, 1, 5 and 9 Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Urine uric acid excretion amount Days -1, 1, 7 and 8 Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Renal clearance of uric acid Days -1, 1 and 7 Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
Fractional excretion of uric acid Days -1, 1, 7 and 8 Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Renal Clearance of Uric Acid Days -1, 1, 7 and 8 Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Cmax Days -1, 1, 7 and 8 Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Time of Occurrence of maximum observed concentration (Tmax) Days -1, 1, 5 and 9 Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
Area under the plasma concentration time curve (AUC) Days -1, 1, 5 and 9 Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
AUC Days -1, 1, 7 and 8 Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Tmax Days -1, 1, 7 and 8 Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Serum urate concentration Days -1, 1, 7 and 8 Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events in terms of vital signs 6 weeks Incidence of Adverse Events in terms of changes in laboratory parameters 6 weeks Incidence of Adverse Events in terms of electrocardiogram parameters 6 weeks Incidence of Adverse Events in terms of physical examination findings 6 weeks Apparent terminal half-life (t1/2) Days -1, 1, 5 and 9 Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine
t1/2 Days -1, 1 and 7 Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine