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RDEA3170 and Allopurinol Combination Study in Gout Subjects

NCT ID: NCT02279641

Last Updated: 2017-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2015-09-11

Brief Summary

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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.

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Sequence B

allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Interventions

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RDEA3170 10 mg

Intervention Type DRUG

allopurinol 300 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Hall, MD

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

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Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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RDEA3170-107

Identifier Type: -

Identifier Source: org_study_id