Metformin and Furosemide Drug-Drug Interaction Study

Overview[ - collapse ][ - ]

Purpose This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.
ConditionHealthy
InterventionDrug: Lesinurad 400 mg
Drug: Metformin 850 mg
Drug: Furosemide 40 mg
PhasePhase 1
SponsorArdea Biosciences, Inc.
Responsible PartyArdea Biosciences, Inc.
ClinicalTrials.gov IdentifierNCT02028689
First ReceivedOctober 17, 2013
Last UpdatedFebruary 13, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateOctober 17, 2013
Last Updated DateFebruary 13, 2014
Start DateOctober 2013
Estimated Primary Completion DateJanuary 2014
Current Primary Outcome Measures
  • PK profile of metformin and furosemide from plasma [Time Frame: Day 1 and Day 5] [Designated as safety issue: No]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] [Designated as safety issue: No]Profile in terms of renal clearance (CLr) and amount of compound excreted into urine unchanged (Ae).
Current Secondary Outcome MeasuresIncidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [Time Frame: 5 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin and Furosemide Drug-Drug Interaction Study
Official TitleA 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
Brief Summary
This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of
metformin and furosemide in healthy, adult male subjects.
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).
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
ConditionHealthy
InterventionDrug: Lesinurad 400 mg
Drug: Metformin 850 mg
Drug: Furosemide 40 mg
Study Arm (s)
  • 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment23
Estimated Completion DateJanuary 2014
Estimated Primary Completion DateNovember 2013
Eligibility Criteria
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.
GenderMale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02028689
Other Study ID NumbersRDEA594-128
Has Data Monitoring CommitteeNo
Information Provided ByArdea Biosciences, Inc.
Study SponsorArdea Biosciences, Inc.
CollaboratorsNot Provided
Investigators Study Director: S. Bradley Ardea Biosciences, Inc.
Verification DateFebruary 2014

Locations[ + expand ][ + ]

United States, Michigan
Kalamazoo, Michigan, United States, 49007