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Completed

NCT Number: NCT02028689

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kalamazoo, Michigan, 49007, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lesinurad 400 mg

Drug

Metformin 850 mg

Drug

Furosemide 40 mg

Drug

Primary outcomes

  1. 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).

  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 outcomes

  1. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 7, 2014
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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