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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