Study identifier:D5491L00001
ClinicalTrials.gov identifier:NCT02317861
EudraCT identifier:N/A
CTIS identifier:N/A
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
Gout and Asymptomatic Hyperuricemia
Phase 1/2
No
RDEA3170, Febuxostat, Benzbromarone
Male
72
Interventional
20 Years - 70 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jan 2020 by AstraZeneca
AstraZeneca
Ardea Biosciences, Inc.
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 |