Status:
COMPLETED
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Hyperuricemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
Eligibility Criteria
Inclusion
- Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL.
- Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout.
- Patient is willing and able to give informed consent and adhere to visit/protocol schedules
- All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap).
Exclusion
- Consumes more than 14 drinks of alcohol per week.
- History or suspicion of drug abuse.
- History of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction.
- Diabetes Mellitus requiring treatment
- Confirmed or suspected HIV-1 infection.
- Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia.
- Uncontrolled hypertension.
- Inadequate renal function.
- Hemoglobin \< 8 g/dL (males) or \< 7 g/dL (females).
- ALT, AST , or GGT 2 x ULN
- Active peptic ulcer disease.
- Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim.
- Pregnant or breast feeding.
- Use of an investigational drug within 4 weeks prior to study drug administration.
- Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations.
- Any other medical or psychological condition which, in the opinion of the investigator, 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.
- History of cardiac abnormalities including abnormal and clinically relevant ECG changes.
- Conditions predisposing to QT prolongation.
- Any use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day 1.
- Subjects with a QTcF interval \>450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00741442
Start Date
July 1 2008
End Date
September 1 2009
Last Update
February 6 2014
Active Locations (1)
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1
Toronto, Ontario, Canada, M9W 4L6