Gout
Conditions
Brief summary
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
Interventions
DRUGRDEA3170 4.5 mg
DRUGRDEA3170 6 mg
DRUGRDEA3170 12 mg
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of Adverse Events in terms of changes in laboratory parameters | 6 weeks | — |
Countries
United States
Outcome results
None listed