Metformin and Furosemide Drug-Drug Interaction Study

NCT ID: NCT02028689

Last Updated: 2014-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Lesinurad 400 mg

Intervention Type DRUG

Metformin 850 mg

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Lesinurad 400 mg

Intervention Type DRUG

Furosemide 40 mg

Intervention Type DRUG

Interventions

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Lesinurad 400 mg

Intervention Type DRUG

Metformin 850 mg

Intervention Type DRUG

Furosemide 40 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Bradley

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

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Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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RDEA594-128

Identifier Type: -

Identifier Source: org_study_id

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