RDEA3170 and Febuxostat Combination Study in Gout Subjects

Study identifier:RDEA3170-204

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

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

Medical condition

Gout

Phase

Phase 2

Healthy volunteers

No

Study drug

RDEA3170 15 mg, RDEA3170 10 mg, RDEA3170 2.5, RDEA3170 5 mg, Febuxostat 40 mg, Febuxostat 80 mg

Sex

All

Actual Enrollment

200

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Oct 2014
Primary Completion Date: 01 Jul 2015
Estimated Study Completion Date: 01 Dec 2015

Study design

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

Verification:

Verified 01 Nov 2015 by Ardea Biosciences, Inc.

Sponsors

Ardea Biosciences, Inc.

Collaborators

-

Inclusion and exclusion criteria