A PD/Safety study of RDEA3170 in combination with Febuxostat for treating gout or asymptomatic hyperuricemia patients

Study identifier:D5491L00001

ClinicalTrials.gov identifier:NCT02317861

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2a, Randomized, Open-Label, Single-Site Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination with Febuxostat Compared to RDEA3170 Administered Alone and Febuxostat Administered Alone, respectively in Japanese Adult Male Subjects with Gout or Asymptomatic Hyperuricemia

Medical condition

Gout and Asymptomatic Hyperuricemia

Phase

Phase 1/2

Healthy volunteers

No

Study drug

RDEA3170, Febuxostat, Benzbromarone

Sex

Male

Actual Enrollment

72

Study type

Interventional

Age

20 Years - 70 Years

Date

Study Start Date: 22 Dec 2014
Primary Completion Date: 06 Jun 2015
Study Completion Date: 06 Jun 2015

Study design

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

Verification:

Verified 01 Jan 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Ardea Biosciences, Inc.

Inclusion and exclusion criteria