A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients
NCT02317861 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2015-06-12
Summary
The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.
Conditions
- Gout and Asymptomatic Hyperuricemia
Interventions
- DRUG
-
RDEA3170
Oral Treatment
- DRUG
-
Febuxostat
Oral Treatment
- DRUG
-
Benzbromarone
Oral Treatment
Sponsors & Collaborators
-
Ardea Biosciences, Inc.
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- Japan
Study Locations
More Related Trials
-
A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
NCT03316131 ·Status: COMPLETED ·Phase: PHASE2
-
RDEA3170 PK/PD Study
NCT02608710 ·Status: COMPLETED ·Phase: PHASE1
-
Single and Multiple Dose Study in Japanese Subjects
NCT01872832 ·Status: COMPLETED ·Phase: PHASE1
-
RDEA3170 and Febuxostat Drug Interaction Study
NCT01883167 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
NCT01510769 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
NCT02082769 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
NCT00174915 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
NCT05513976 ·Status: UNKNOWN ·Phase: PHASE2
-
RDEA3170 Bioavailability Study
NCT02336594 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
NCT01082640 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Oral Febuxostat in Participants With Gout
NCT00430248 ·Status: COMPLETED ·Phase: PHASE3
-
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
NCT00175019 ·Status: COMPLETED ·Phase: PHASE3
-
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
NCT03372200 ·Status: COMPLETED ·Phase: PHASE3
-
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
NCT03100318 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
NCT00741442 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
NCT01078389 ·Status: COMPLETED ·Phase: PHASE2
-
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
NCT03118739 ·Status: COMPLETED ·Phase: PHASE2
-
Gout Dose Response Study
NCT00955981 ·Status: COMPLETED ·Phase: PHASE2
-
Mild, Moderate and Severe Renal Impairment Study
NCT02219516 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
NCT00995618 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
NCT00174967 ·Status: COMPLETED ·Phase: PHASE2
-
Allopurinol Combination Study
NCT01001338 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
NCT01736514 ·Status: COMPLETED ·Phase: PHASE3
-
Long-Term Safety of Febuxostat in Subjects With Gout.
NCT00174941 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Exploratory Clinical Study of KUX-1151
NCT02190786 ·Status: COMPLETED ·Phase: PHASE2