RDEA3170 and Allopurinol Combination Study in Gout Subjects

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: RDEA3170 10 mg; Drug: allopurinol 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02279641

RDEA3170-107

Details and patient eligibility

About

This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
• Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
• Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
• Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion criteria

• Subject is unable to take colchicine for gout flare prophylaxis.
• Subject has a history or suspicion of kidney stones.
• Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
• Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
• Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
• Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Sequence A

Experimental group

Description:

RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd

Treatment:

Drug: allopurinol 300 mg

Drug: RDEA3170 10 mg

Sequence B

Experimental group

Description:

allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd

Treatment:

Drug: allopurinol 300 mg

Drug: RDEA3170 10 mg