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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02246673
Other study ID # RDEA3170-204
Secondary ID
Status Completed
Phase Phase 2
First received September 19, 2014
Last updated August 31, 2016
Start date October 2014
Est. completion date February 2016

Study information

Verified date August 2016
Source Ardea Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date February 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
RDEA3170 15 mg

RDEA3170 10 mg

RDEA3170 2.5

RDEA3170 5 mg

Febuxostat 40 mg

Febuxostat 80 mg


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PD profile of multiple-dose RDEA3170 administered in combination with febuxostat Serial serum and urine samples measured at various timepoints during screening, Days -1, 1, 7, 14, 21 and 28.
PD endpoints in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.
Screening to Day 28 No
Secondary PK profile of multiple-dose RDEA3170 administered with febuxostat from plasma erial plasma samples measured on Days 7, 14, 21 and 28 PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); apparent terminal half-life (t1/2) Days 7 to Day 28 No
Secondary Incidence of Adverse Events Changes in Laboratory, Electrocardiogram and Vital Signs Parameters 10 weeks Yes
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