Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

Ardea Biosciences

Status and phase: Completed; Phase 2

Conditions: Gout

Treatments: Drug: RDEA3170 2.5 mg; Drug: allopurinol 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02498652

RDEA3170-206

Details and patient eligibility

About

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
• 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.
• 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 any gastrointestinal disorder that affects motility and/or absorption.
• Subject had unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
• Subject has Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
• Subject has an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
• Subject is taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

RDEA3170 2.5 mg, 7.5 mg and 15 mg

Experimental group

Description:

RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid))

Treatment:

Drug: RDEA3170 2.5 mg

Drug: allopurinol 300 mg

RDEA3170 5 mg, 10 mg and 20 mg

Experimental group

Description:

RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)

Treatment:

Drug: RDEA3170 2.5 mg

Drug: allopurinol 300 mg