DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 plasma

PK 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017