A Phase 1 interventional study of Lesinurad 400 mg and Metformin 850 mg in Healthy, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Ardea Biosciences, Inc. · Phase 1, Interventional, and Basic science
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).
Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
PK profile of metformin and furosemide from plasma
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).
Time frame: Day 1 and Day 5
PK profile of furosemide from urine
Profile in terms of renal clearance (CLr) and amount of compound excreted into urine unchanged (Ae).
Time frame: Day 1 and Day 5
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
Time frame: 5 weeks
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Ardea Biosciences, Inc.