Metformin and Furosemide Drug-Drug Interaction Study
Information source: Ardea Biosciences, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Lesinurad 400 mg (Drug); Metformin 850 mg (Drug); Furosemide 40 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Ardea Biosciences, Inc. Official(s) and/or principal investigator(s): S. Bradley, Study Director, Affiliation: Ardea Biosciences, Inc.
Summary
This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of
metformin and furosemide in healthy, adult male subjects.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: PK profile of metformin and furosemide from plasmaPK profile of furosemide from urine
Secondary outcome: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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.
Locations and Contacts
Kalamazoo, Michigan 49007, United States
Additional Information
Starting date: October 2013
Last updated: February 13, 2014
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