Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Study identifier:RDEA3170-206
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 Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout
Medical condition
Gout
Phase
Phase 2
Healthy volunteers
No
Study drug
RDEA3170 2.5 mg, allopurinol 300 mg
Sex
All
Actual Enrollment
40
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Jul 2015
Estimated Primary Completion Date: 01 Dec 2015
Estimated Study Completion Date: 01 Jan 2016
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: RDEA3170 2.5 mg, 7.5 mg and 15 mg RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid)) | Drug: RDEA3170 2.5 mg Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets). Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets). Drug: allopurinol 300 mg allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets) |
| Experimental: RDEA3170 5 mg, 10 mg and 20 mg RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid) | Drug: RDEA3170 2.5 mg Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets). Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets). Drug: allopurinol 300 mg allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets) |
Contacts
Investigators
Principal Investigator
Jesse Hall
Ardea Biosciences, Inc.
