Metformin and Furosemide Drug-Drug Interaction Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028689

Enrollment

Registered

2014-01-07

Start date

2013-10-31

Completion date

2014-01-31

Last updated

2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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).

Interventions

DRUGLesinurad 400 mg

DRUGMetformin 850 mg

DRUGFurosemide 40 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
PK profile of metformin and furosemide from plasma	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).
PK profile of furosemide from urine	Day 1 and Day 5	Profile in terms of renal clearance (CLr) and amount of compound excreted into urine unchanged (Ae).

Secondary

Measure	Time frame
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters	5 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026