Lesinurad Interaction Study With Ranitidine
Study identifier:RDEA594-127
ClinicalTrials.gov identifier:NCT01908257
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
lesinurad 400 mg, ranitidine 150 mg, lesinurad 400 mg + ranitidine 150 mg
Sex
Male
Actual Enrollment
16
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jul 2013
Primary Completion Date: 01 Sept 2013
Study Completion Date: 01 Nov 2013
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2014 by Ardea Biosciences, Inc.
Sponsors
Ardea Biosciences, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence 1 fasted Day 1: Lesinurad 400 mg once daily (qd) Day 5: Ranitidine 150 mg twice daily (bid) Day 6: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad. Day 7: Ranitidine 150 mg (bid) | - |
| Experimental: Sequence 2 fasted Day 1: Ranitidine 150 mg (bid) Day 2: Lesinurad 400 mg (qd) + ranitidine 150 mg (bid). Ranitidine dosed at -2 hours predose and 12 hours postdose of lesinurad Day 3: Ranitidine 150 mg (bid) Day 7: Lesinurad 400 mg (qd) | - |
Contacts
Investigators
Principal Investigator
S. Bradley
Ardea Biosciences, Inc.
