Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters

Description

The objective of this study is to confirm the feasibility of using a panel of endogenous substrates/metabolites as a robust biomarker of OCTs and OATs by conducting a controlled, comprehensive clinical drug-drug interaction study in healthy adult volunteers. Metformin and furosemide will be used as probe drugs for OCTs and OATs, respectively; cimetidine and probenecid will be used as corresponding inhibitors. Results from this study will validate this novel approach, which will be extended to children by collaborators at Children's Mercy Hospital in Kansas City, MO.

Conditions

Interaction, Endogenous Biomarkers

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Study Overview

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Study Details

Study overview

The objective of this study is to confirm the feasibility of using a panel of endogenous substrates/metabolites as a robust biomarker of OCTs and OATs by conducting a controlled, comprehensive clinical drug-drug interaction study in healthy adult volunteers. Metformin and furosemide will be used as probe drugs for OCTs and OATs, respectively; cimetidine and probenecid will be used as corresponding inhibitors. Results from this study will validate this novel approach, which will be extended to children by collaborators at Children's Mercy Hospital in Kansas City, MO.

Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters

Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters

Condition
Interaction
Intervention / Treatment

-

Contacts and Locations

Spokane

Washington State University College of Pharmacy and Pharmaceutical Sciences, Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Are not taking any medications (prescription and non-prescription) or dietary/herbal supplements that can interfere with your ability to eliminate the study drugs from your body
  • * Are willing to stop taking dietary/herbal supplements and citrus juices for several weeks
  • * Are willing to stop consuming caffeinated beverages or other caffeine-containing products the evening before and the morning of the first day of each study arm
  • * Are willing to stop drinking alcoholic beverages for at least 1 day prior to any study day and during the study day
  • * Are willing to use an acceptable method of birth control that does not include oral contraceptive pills or patches (such as abstinence, copper IUD, condom) throughout your participation in the study and for at least 3 weeks after you last take the study drugs
  • * Have the time to participate
  • * Are under 18 or over 65 years old
  • * Smoke/vape/chew tobacco products
  • * Use cannabis products, including marijuana, hemp, and other THC- and CBDcontaining products• Are taking medications or dietary/herbal supplements that can interfere with your ability to eliminate the study drugs from your body
  • * Have a chronic illness such as (but not limited to) kidney disease, liver disease, diabetes mellitus, high blood pressure, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
  • * Have a hematologic (blood) disorder
  • * Have a history of drug or alcohol addiction or major psychiatric illness
  • * Have a history of allergy to metformin, cimetidine, furosemide, or probenecid
  • * Are pregnant, nursing, or plan to become pregnant within 3 weeks after participation

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington State University,

Study Record Dates

2026-07-22