NSAID Drug Interaction Study
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.
Drug: lesinurad 400 mg
Drug: naproxen 250 mg
Drug: indomethacin 25 mg
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects|
- PK profile of lesinurad from plasma and urine [ Time Frame: Day 1, Day 6 (urine only), Day 7, Day 14 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1, Day 6 (urine only), Day 7, Day 14 ] [ Designated as safety issue: No ]Profile in terms of AUC, Tmax, Cmax, and t1/2
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Lesinurad 400 mg and naproxen 250 mg
Lesinurad once daily (qd) Day 1, naproxen twice daily (bid) Day 2-6, lesinurad qd with naproxen bid Day 7-14.
|Drug: lesinurad 400 mg Drug: naproxen 250 mg|
Active Comparator: Lesinurad 400 mg and indomethacin 25 mg
Lesinurad qd Day 1, indomethacin bid Day 2-6, lesinurad qd with indomethacin bid Day 7-14.
|Drug: lesinurad 400 mg Drug: indomethacin 25 mg|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01884272
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|Study Director:||S Bradley, MD||Ardea Biosciences, Inc.|