Status:
COMPLETED
Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters
Lead Sponsor:
Washington State University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Conditions:
Interaction
Endogenous Biomarkers
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
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 clinica...
Detailed Description
The kidneys are major organs responsible for the excretion of both endogenous and exogenous compounds, the latter including drugs and other xenobiotics. Excretion occurs via passive or active processe...
Eligibility Criteria
Inclusion
- Are from 18-65 years old and healthy
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05365451
Start Date
April 11 2022
End Date
July 22 2023
Last Update
August 8 2025
Active Locations (1)
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1
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, United States, 99202