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

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington State University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Cimetidine; Furosemide; Metformin; Probenecid

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