Study on kidney transporters using drug interactions

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

This study is testing if certain drugs can help us understand how well kidney transporters are working in healthy adults, which could lead to safer ways to check kidney function, especially in kids.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Washington State University (other)
• Locations: 1 site (Spokane, Washington)
• Trial ID: NCT05365451 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the feasibility of using endogenous substrates as biomarkers for kidney transporters by conducting a controlled drug-drug interaction study in healthy adults. Participants will receive metformin and furosemide as probe drugs, with cimetidine and probenecid as inhibitors, to assess the impact on renal transporter function. The findings could lead to a novel approach for evaluating kidney function, particularly in children, where traditional methods may pose risks. The study will be conducted at Washington State University with collaboration from national health institutes.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 who are not taking any medications or supplements that could interfere with the study drugs.

Not a fit: Patients under 18 or over 65 years old, or those who smoke or use tobacco products, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer method for assessing kidney function in both adults and children.

How similar studies have performed: While the use of endogenous biomarkers is a promising approach, this specific methodology is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

* 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

Where this trial is running

Spokane, Washington

• Washington State University College of Pharmacy and Pharmaceutical Sciences — Spokane, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Mary Paine, RPh, PhD

Conditions: Interaction, Endogenous Biomarkers, Kidney Transporter, Pharmacokinetics