CompletedNCT01884272Updated Nov 8, 2013

NSAID Drug Interaction Study

A Phase 1 interventional study of lesinurad 400 mg and naproxen 250 mg in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by Ardea Biosciences, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: Male

Study 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.

Read the 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.

Conditions studied

Gout

In context

Lead sponsor

Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts 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

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

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

Interventions

Druglesinurad 400 mg
Drugnaproxen 250 mg
Drugindomethacin 25 mg

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Kalamazoo, Michigan 49007, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01884272
Lead sponsor: Ardea Biosciences, Inc.
Responsible party: Sponsor
First posted: Jun 24, 2013
Start date: Jun 2013
Primary completion: Aug 2013
Completion: Oct 2013
Last update: Nov 8, 2013

Study contacts

S Bradley, MD

study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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