RDEA3170 and Febuxostat Combination Study in Gout Subjects

Gout Clinical Trial

Official title:

A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246673
• Other study ID #: RDEA3170-204
• 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

• Gout

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