A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Ardea Biosciences

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: Placebo; Drug: RDEA806

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741442

RDEA806-501

Details and patient eligibility

About

The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

3 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

RDEA806 400 mg qd

Treatment:

Drug: RDEA806

3

Experimental group

Description:

RDEA806 400 mg bid

Treatment:

Drug: RDEA806

2

Placebo Comparator group

Description:

Placebo QD

Treatment:

Drug: Placebo

4

Placebo Comparator group

Description:

Placebo BID

Treatment:

Drug: Placebo