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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

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.


  • Drug: lesinurad 400 mg
  • Drug: naproxen 250 mg
  • Drug: indomethacin 25 mg

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • PK profile of lesinurad from plasma and urine
    • Time Frame: 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
    • Time Frame: Day 1, Day 6 (urine only), Day 7, Day 14
    • Profile in terms of AUC, Tmax, Cmax, and t1/2

Secondary Measures

  • Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
    • Time Frame: 13 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ardea Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • S Bradley, MD, Study Director, Ardea Biosciences, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.