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Metformin and Furosemide Drug-Drug Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02028689
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lesinurad 400 mg Drug: Metformin 850 mg Drug: Furosemide 40 mg Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02028689

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United States, Michigan
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Ardea Biosciences, Inc.
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Study Director: S. Bradley Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc. Identifier: NCT02028689     History of Changes
Other Study ID Numbers: RDEA594-128
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Natriuretic Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Antirheumatic Agents
Uricosuric Agents
Renal Agents