Metformin and Furosemide Drug-Drug Interaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02028689
First received: October 17, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Lesinurad 400 mg
Drug: Metformin 850 mg
Drug: Furosemide 40 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Ardea Biosciences, Inc.:

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).


Secondary Outcome Measures:
  • Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: October 2013
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Drug: Lesinurad 400 mg Drug: 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

Drug: Lesinurad 400 mg Drug: Furosemide 40 mg

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028689

Locations
United States, Michigan
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: S. Bradley Ardea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02028689     History of Changes
Other Study ID Numbers: RDEA594-128
Study First Received: October 17, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Furosemide
Metformin
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 26, 2014