We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

NSAID Drug Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01884272
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Gout Drug: lesinurad 400 mg Drug: naproxen 250 mg Drug: indomethacin 25 mg Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 2013
Primary Completion Date : August 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 13 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884272

United States, Michigan
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Ardea Biosciences, Inc.
Study Director: S Bradley, MD Ardea Biosciences, Inc.

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01884272     History of Changes
Other Study ID Numbers: RDEA594-126
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Uricosuric Agents
Renal Agents