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Transporter Inhibitor

Probenecid 500 MG for Biomarkers

Phase < 1
Waitlist Available
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours
Awards & highlights

Study Summary

This trial is testing whether a combination of drugs can be used as a marker for other drugs' effects on the body, in order to more easily study how those drugs affect children.

Eligible Conditions
  • Interactions
  • Biomarkers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Furosemide area under the concentration vs. time curve (AUC)
Furosemide area under the concentration vs. time curve (AUC) in presence of probenecid
Furosemide maximum concentration (Cmax)
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 2B: furosemide + probenecidExperimental Treatment2 Interventions
Arm 2B will consist of administration of a single oral dose of probenecid (1,000 mg) with water by mouth. One hour later, furosemide (5 mg) will be administered by mouth as a liquid. Plasma and urine will be collected from 0-24 hours. Participants may or may not elect to participate in Arms 1A and 1B. A washout of at least 7 days will occur between Arm 2B and Arm 1A.
Group II: Arm 2A: furosemide alone (baseline)Experimental Treatment1 Intervention
Arm 2A will consist of administration of a single dose of furosemide (5 mg) by mouth as a liquid. Plasma and urine will be collected from 0-24 hours. A washout of at least 7 days will occur between Arm 2A and Arm 2B.
Group III: Arm 1B: metformin + cimetidineExperimental Treatment2 Interventions
Arm 1B will consist of administration of a single oral dose of cimetidine (400 mg) with water by mouth. One hour later, metformin (50 mg) will be administered by mouth as a liquid. Plasma and urine will be collected from 0-24 hours. Participants may or may not elect to participate in Arms 2A and 2B. A washout of at least 7 days will occur between Arm 1B and Arm 2A.
Group IV: Arm 1A: metformin alone (baseline)Experimental Treatment1 Intervention
Arm 1A will consist of administration of a single dose of metformin (50 mg) by mouth as a liquid to 16 subjects (8 males, 8 females). Plasma and urine will be collected from 0-24 hours. Participants may or may not elect to participate in Arms 2A and 2B. A washout of at least 7 days will occur between Arm 1A and Arm 1B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probenecid 500 MG
2022
Completed Early Phase 1
~40
MetFORMIN Oral Solution
2022
Completed Early Phase 1
~40
Cimetidine 400 MG
2022
Completed Early Phase 1
~40
Furosemide Oral Liquid Product
2022
Completed Early Phase 1
~40

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,548 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,709 Total Patients Enrolled
Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,682 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity for enrollment in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is currently enrolling patients, having been initially posted on April 11th 2022 and most recently updated on September 8th 2022. The research requires 32 participants from 1 medical centre."

Answered by AI

Is admission to this clinical trial contingent upon age, with those over thirty years excluded?

"For a successful enrolment in this medical study, participants must be aged between 18 and 65 years old."

Answered by AI

Are there any opportunities for individuals to join this research?

"Affirmative. Clinicaltrials.gov data highlights that this medical test, which was first announced on April 11th 2022, is currently in search of participants. 32 individuals are required to be enrolled from a single site location."

Answered by AI

Can I be accepted as a participant in this research study?

"This research is seeking 32 individuals aged 18 to 65 for a trial of interactions. Participants must meet the following conditions: between ages 18 and 65, abstain from medicine or dietary supplements that could impede metabolism of study drugs, cut out caffeine-containing products in evenings and mornings before/during each arm phase, no alcohol consumption for 24 hours prior to any study day plus throughout duration of it., use an approved birth control method not involving oral contraceptives nor patches (such as abstinence, copper IUDs, condoms) while participating plus 3 weeks after last medication ingestion ,and have available time during course of experiment."

Answered by AI
Recent research and studies
Annual Review of Pharmacology and ToxicologyJournal
Renal Transporters in Drug Development
Morrissey, Kari M., Sophie L. Stocker, Matthias B. Wittwer, Lu Xu, and Kathleen M. Giacomini. 2013. “Renal Transporters in Drug Development”. Annual Review of Pharmacology and Toxicology. Annual Reviews. doi:10.1146/annurev-pharmtox-011112-140317.
Journal of Pharmacology and Experimental TherapeuticsJournal
Evidence for the Validity of Pyridoxic Acid (PDA) as a Plasma-based Endogenous Probe for OAT1 and OAT3 Function in Healthy Subjects
Shen, Hong, Vinay K. Holenarsipur, T. Thanga Mariappan, Dieter M. Drexler, Joseph L. Cantone, Prabhakar Rajanna, Shashyendra Singh Gautam, et al.. 2018. “Evidence for the Validity of Pyridoxic Acid (PDA) as a Plasma-based Endogenous Probe for OAT1 and OAT3 Function in Healthy Subjects”. Journal of Pharmacology and Experimental Therapeutics. American Society for Pharmacology & Experimental Therapeutics (ASPET). doi:10.1124/jpet.118.252643.
nJournal
Elucidation of <i>n</i><sup>1</sup>-methyladenosine as a Potential Surrogate Biomarker for Drug Interaction Studies Involving Renal Organic Cation Transporters
Miyake, Takeshi, Tadahaya Mizuno, Issey Takehara, Tatsuki Mochizuki, Miyuki Kimura, Shunji Matsuki, Shin Irie, et al.. 2019. “Elucidation of n1-methyladenosine as a Potential Surrogate Biomarker for Drug Interaction Studies Involving Renal Organic Cation Transporters”. Drug Metabolism and Disposition. American Society for Pharmacology & Experimental Therapeutics (ASPET). doi:10.1124/dmd.119.087262.
Expert Opinion on Drug Metabolism & ToxicologyJournal
Potential Implications of DMET Ontogeny on the Disposition of Commonly Prescribed Drugs in Neonatal and Pediatric Intensive Care Units
Naji-Talakar, Siavosh, Sheena Sharma, Leslie A. Martin, Derek Barnhart, and Bhagwat Prasad. 2021. “Potential Implications of DMET Ontogeny on the Disposition of Commonly Prescribed Drugs in Neonatal and Pediatric Intensive Care Units”. Expert Opinion on Drug Metabolism & Toxicology. Informa UK Limited. doi:10.1080/17425255.2021.1858051.
~11 spots leftby Apr 2025
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