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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 The half of patients randomized to this cohort will be dosed in the order of Febuxostat 10mg, RDEA3170 2.5 mg + Febuxostat 10mg, RDEA3170 2.5 mg + Febuxostat 20mg, and Febuxostat 20mg. The other half will be dosed in the reverse order. | Drug: RDEA3170 Oral Treatment Drug: Febuxostat Oral Treatment |
| Experimental: Cohort 2 The half of patients randomized to this cohort will be dosed in the order of Febuxostat 10mg, RDEA3170 5 mg + Febuxostat 10mg, RDEA3170 5 mg + Febuxostat 20mg, and Febuxostat 20mg. The other half will be dosed in the reverse order. | Drug: RDEA3170 Oral Treatment Drug: Febuxostat Oral Treatment |
| Experimental: Cohort 3 The half of patients randomized to this cohort will be dosed in the order of Febuxostat 20mg, RDEA3170 5 mg + Febuxostat 20mg, RDEA3170 5 mg + Febuxostat 40mg, and Febuxostat 40mg. The other half will be dosed in the reverse order. | Drug: RDEA3170 Oral Treatment Drug: Febuxostat Oral Treatment |
| Experimental: Cohort 4 The half of patients randomized to this cohort will be dosed in the order of Febuxostat 20mg, RDEA3170 10 mg + Febuxostat 20mg, RDEA3170 10 mg + Febuxostat 40mg, and Febuxostat 40mg. The other half will be dosed in the reverse order. | Drug: RDEA3170 Oral Treatment Drug: Febuxostat Oral Treatment |
| Experimental: Cohort 5 RDEA3170 2.5mg, RDEA3170 5mg, RDEA3170 10mg, RDEA3170 15mg | Drug: RDEA3170 Oral Treatment |
| Experimental: Cohort 6 The half of patients randomized to this cohort will be dosed in the order of Benzbromarone 50 mg, Febuxostat 10mg+RDEA3170 2.5 mg, then Febuxostat 20mg+RDEA3170 5 mg. The other half will be dosed in the order of Febuxostat 10mg+RDEA3170 2.5 mg, Febuxostat 20mg+RDEA3170 5 mg, then Benzbromarone 50mg. | Drug: RDEA3170 Oral Treatment Drug: Febuxostat Oral Treatment Drug: Benzbromarone Oral Treatment |
