RDEA3170 and Febuxostat Combination Study in Gout Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RDEA3170 10 mg

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.

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 80 mg

Intervention Type DRUG

RDEA3170 15 mg

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.

Group Type EXPERIMENTAL

RDEA3170 15 mg

Intervention Type DRUG

RDEA3170 5 mg

Intervention Type DRUG

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 80 mg

Intervention Type DRUG

RDEA3170 5 mg

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.

Group Type EXPERIMENTAL

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 80 mg

Intervention Type DRUG

RDEA3170 2.5 mg

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.

Group Type EXPERIMENTAL

RDEA3170 2.5

Intervention Type DRUG

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 80 mg

Intervention Type DRUG

Interventions

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RDEA3170 15 mg

Intervention Type DRUG

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 2.5

Intervention Type DRUG

RDEA3170 5 mg

Intervention Type DRUG

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 80 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No