Study identifier:RDEA594-128
ClinicalTrials.gov identifier:NCT02028689
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy
Phase 1
Yes
Lesinurad 400 mg, Metformin 850 mg, Furosemide 40 mg
Male
23
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Feb 2014 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
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This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.
Leinurad is a weak in vitro inhibitor of the hepatic transporter OCT1 and the renal transporters OAT1 and OAT3 (OAT1/3). To assess the clinical relevance of these in vitro findings, this clinical study will evaluate the effect of lesinurad on the PK of metformin (OCT1 substrate) and furosemide (OAT1/3 substrate).
Location
Location
Kalamazoo, MI, United States, 49007
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 | - |
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