Metformin and Furosemide Drug-Drug Interaction Study
This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.
Drug: Lesinurad 400 mg
Drug: Metformin 850 mg
Drug: Furosemide 40 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- PK profile of metformin and furosemide from plasma [ Time Frame: Day 1 and Day 5 ] [ Designated as safety issue: No ]Profile in terms of maximum observed concentration (Cmax), time of occurence of maximum observed concentration (Tmax), area under the concentration-time curve (AUC), and apparent terminal half-life (t1/2).
- PK profile of furosemide from urine [ Time Frame: Day 1 and Day 5 ] [ Designated as safety issue: No ]Profile in terms of renal clearance (CLr) and amount of compound excreted into urine unchanged (Ae).
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2013|
|Study Completion Date:||January 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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
|Drug: Lesinurad 400 mg Drug: 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
|Drug: Lesinurad 400 mg Drug: Furosemide 40 mg|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02028689
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|Study Director:||S. Bradley||Ardea Biosciences, Inc.|