COMPLETED

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

Conditions

Interaction Endogenous Biomarkers Kidney Transporter Pharmacokinetics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-11

Study Completion:2023-07-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05365451

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Washington State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-11

Study Completion Date2023-07-22

Study Record Updates

Study Start Date2022-04-11

Study Completion Date2023-07-22

Terms related to this study

Keywords Provided by Researchers

Kidney Transporter
Pharmacokinetics

Additional Relevant MeSH Terms

Interaction
Endogenous Biomarkers