Gout
Conditions
Brief summary
This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.
Detailed description
Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.
Interventions
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2. * Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures. * Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
Exclusion criteria
* Subject has clinically significant pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders. * Subject has a history or suspicion of kidney stones. * Subject has a history of asthma. * Subject has undergone major surgery within 3 months prior to Day 1. * Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit. * Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK profile of lesinurad from plasma and urine | Day 1, Day 6 (urine only), Day 7, Day 14 | Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life |
| PK profile of naproxen and indomethacin from plasma and urine | Day 1, Day 6 (urine only), Day 7, Day 14 | Profile in terms of AUC, Tmax, Cmax, and t1/2 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters | 13 weeks |
Countries
United States
Outcome results
None listed