Metformin and Furosemide Drug-Drug Interaction Study
Study identifier:RDEA594-128
ClinicalTrials.gov identifier:NCT02028689
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate Potential Pharmacokinetic Interaction Between Lesinurad and Metformin and Between Lesinurad and Furosemide in Health Adult Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Lesinurad 400 mg, Metformin 850 mg, Furosemide 40 mg
Sex
Male
Actual Enrollment
23
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Oct 2013
Primary Completion Date: 01 Nov 2013
Study Completion Date: 01 Jan 2014
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Feb 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: Lesinurad and Metformin Sequence A- Day 1: Metformin 850 mg; Day 5: Lesinurad 400 mg with metformin 850 mg Sequence B- Day 1: Lesinurad 400 mg with metformin 850 mg; Day 5: Metformin 850 mg | - |
| Experimental: Lesinurad and Furosemide Sequence C - Day 1: Furosemide 40 mg; Day 5: Lesinurad 400 mg with furosemide 40 mg Sequence D - Day 1: Lesinurad 400 mg with furosemide 40 mg; Day 5: Furosemide 40 mg | - |
Contacts
Investigators
Principal Investigator
S. Bradley
Ardea Biosciences, Inc.
