RDEA3170 PK/PD Study

• RDEA3170 4.5 mg (Drug)
• RDEA3170 6 mg (Drug)
• RDEA3170 12 mg (Drug)

Primary outcomes

• 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
• Cmax [Days -1, 1 and 7]: Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
• 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
• Tmax [Days -1, 1 and 7]: Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
• AUC [Days -1, 1 and 7]: Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
• Tmax [Days -1, 1, 7 and 8]: Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
• AUC [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, 5 and 9]: Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
• Urine uric acid excretion amount [Days -1, 1, 5 and 9]: Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
• Renal clearance of uric acid [Days -1, 1, 5 and 9]: Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
• Fractional excretion of uric acid [Days -1, 1, 5 and 9]: Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
• Serum urate concentration [Days -1, 1 and 7]: Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
• Urine uric acid excretion amount [Days -1, 1 and 7]: Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
• 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 and 7]: Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
• Serum urate concentration [Days -1, 1, 7 and 8]: Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
• 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, 7 and 8]: Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
• 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

Secondary outcomes

• 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 vital signs [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, 7 and 8]: Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
• t1/2 [Days -1, 1 and 7]: Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine

Sex: Male, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• J. Hall, MD, Study director, Ardea Biosciences, Inc.