RDEA3170 Monotherapy in Subjects With Gout

Completed · Phase 2 · Has a placebo group

Conditions studied: Gout

In brief

This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.

Key facts

Study ID

NCT01927198

Run by

Ardea Biosciences, Inc.

People needed

172

Starts

2013-08-01

Expected to finish

2014-07-01

Last updated by the study team

2015-07-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject meets the diagnosis of gout per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
• Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.
• Subject has a body mass index < 40 kg/m2.

You may not qualify if…

• Subject is pregnant or breastfeeding. Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
• Subject has a history or suspicion of kidney stones.
• Subject has a history or suspicion of drug abuse within the past 5 years.
• Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.
• Subject has a known or suspected human immunodeficiency virus infection.
• Subject has a positive test for active hepatitis B or hepatitis C infection.
• Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.
• Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
• Subject has a QT interval corrected for heart rate according to Fridericia's formula > 450 msec during the Screening Period, confirmed by a repeat assessment.
• Subject has uncontrolled hypertension.
• Subject has an estimated creatinine clearance < 60 mL/min.
• Subject has an alkaline phosphatase > 2.0 x upper limit of normal during the Screening Period.
• Subject has active liver disease or impaired hepatic function.
• Subject is receiving chronic treatment with more than 325 mg salicylates per day.
• Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.
• Subject is unable to take colchicine for gout flare prophylaxis.
• Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.
• Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.
• Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.
• Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Gulf Shores, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Gold River, California, United States
• Study site — Irvine, California, United States
• Study site — San Leandro, California, United States
• Study site — San Ramon, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Dunwoody, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Meridian, Idaho, United States
• Study site — Gurnee, Illinois, United States
• Study site — Elizabethtown, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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