RDEA3170 and Febuxostat Combination Study in Gout Subjects

Ardea Biosciences

Status and phase: Completed; Phase 2

Conditions: Gout

Treatments: Drug: RDEA3170 15 mg; Drug: Febuxostat 40 mg; Drug: RDEA3170 10 mg; Drug: RDEA3170 5 mg; Drug: Febuxostat 80 mg; Drug: RDEA3170 2.5

Study type: Interventional

Funder types: Industry

Identifiers

NCT02246673

RDEA3170-204

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
• 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.
• Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.
• Screening serum urate level ≥ 8 mg/dL.
• Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion criteria

• Unable to take colchicine for gout flare prophylaxis.
• History or suspicion of kidney stones.
• Any gastrointestinal disorder that affects motility and/or absorption.
• 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.
• Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
• Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
• 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.
• 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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64 participants in 4 patient groups

RDEA3170 10 mg

Experimental group

Description:

Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

Treatment:

Drug: Febuxostat 80 mg

Drug: Febuxostat 40 mg

Drug: RDEA3170 10 mg

RDEA3170 15 mg

Experimental group

Description:

Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

Treatment:

Drug: Febuxostat 80 mg

Drug: Febuxostat 40 mg

Drug: RDEA3170 5 mg

Drug: RDEA3170 15 mg

RDEA3170 5 mg

Experimental group

Description:

Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

Treatment:

Drug: Febuxostat 80 mg

Drug: Febuxostat 40 mg

RDEA3170 2.5 mg

Experimental group

Description:

Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

Treatment:

Drug: Febuxostat 80 mg

Drug: Febuxostat 40 mg

Drug: RDEA3170 2.5