Metformin and Furosemide Drug-Drug Interaction Study
Overview
This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: November 2013
Detailed Description
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).
Interventions
- Drug: Lesinurad 400 mg
- Drug: Metformin 850 mg
- Drug: Furosemide 40 mg
Arms, Groups and Cohorts
- 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
Clinical Trial Outcome Measures
Primary Measures
- PK profile of metformin and furosemide from plasma
- Time Frame: Day 1 and Day 5
- 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
- Profile in terms of renal clearance (CLr) and amount of compound excreted into urine unchanged (Ae).
Secondary Measures
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
- Time Frame: 5 weeks
Participating in This Clinical Trial
Inclusion Criteria
- Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2. – Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment. Exclusion Criteria:
- Subject has a history or suspicion of kidney stones, prostatic hyperplasia, or urinary stricture. – Subject has undergone major surgery within 3 months prior to Screening. – Subject donated blood or experienced significant blood loss (>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening. – Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Ardea Biosciences, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- S. Bradley, Study Director, Ardea Biosciences, Inc.
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