MedTrace Logo

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

NCT05365451 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Interaction
  • Endogenous Biomarkers

Interventions

DRUG

MetFORMIN Oral Solution

liquid

DRUG

Cimetidine 400 MG

tablet

DRUG

Furosemide Oral Liquid Product

oral solution

DRUG

Probenecid 500 MG

tablet

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Washington State University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-07-22
Completion
2023-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365451 on ClinicalTrials.gov