NSAID Drug Interaction Study



Status:Completed
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 55
Updated:11/23/2013
Start Date:June 2013
End Date:October 2013
Contact:T Boyea
Phone:858-735-0630

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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


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.


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.

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.
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