Eligibility
18+
All Sexes
What conditions do you have?
Select
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. Probenecid 500 MG is used to treat Interactions and has been previously approved by the FDA for a different condition. No patients in this trial will receive a placebo. This treatment is free.
Eligible Conditions
- Interactions
- Tumor Markers
Treatment Effectiveness
Effectiveness Progress
Study Objectives
21 Primary · 0 Secondary · Reporting Duration: 0-24 hours
0-24 hours
Endogenous substrate area under the concentration vs. time curve (AUC)
Endogenous substrate area under the concentration vs. time curve (AUC) in presence of cimetidine
Endogenous substrate area under the concentration vs. time curve (AUC) in presence of probenecid
Endogenous substrate maximum concentration (Cmax)
Endogenous substrate maximum concentration (Cmax) in presence of cimetidine
Endogenous substrate maximum concentration (Cmax) in presence of probenecid
Endogenous substrate renal clearance (CLr)
Endogenous substrate renal clearance (CLr) in presence of cimetidine
Endogenous substrate renal clearance (CLr) in presence of probenecid
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)
Furosemide maximum concentration (Cmax) in presence of probenecid
Furosemide renal clearance (CLr)
Furosemide renal clearance (CLr) in presence of probenecid
Metformin area under the concentration vs. time curve (AUC)
Metformin area under the concentration vs. time curve (AUC) in presence of cimetidine
Metformin maximum concentration (Cmax)
Metformin maximum concentration (Cmax) in presence of cimetidine
Metformin renal clearance (CLr)
Metformin renal clearance (CLr) in presence of cimetidine
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Arm 2B: furosemide + probenecid
1 of 4
Arm 2A: furosemide alone (baseline)
1 of 4
Arm 1B: metformin + cimetidine
1 of 4
Arm 1A: metformin alone (baseline)
1 of 4
Experimental Treatment
32 Total Participants · 4 Treatment Groups
Primary Treatment: Probenecid 500 MG · No Placebo Group · Phase < 1
Arm 2B: furosemide + probenecidExperimental Group · 2 Interventions: Furosemide Oral Liquid Product, Probenecid 500 MG · Intervention Types: Drug, Drug
Arm 2A: furosemide alone (baseline)
Drug
Experimental Group · 1 Intervention: Furosemide Oral Liquid Product · Intervention Types: DrugArm 1B: metformin + cimetidineExperimental Group · 2 Interventions: MetFORMIN Oral Solution, Cimetidine 400 MG · Intervention Types: Drug, Drug
Arm 1A: metformin alone (baseline)
Drug
Experimental Group · 1 Intervention: MetFORMIN Oral Solution · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-24 hours
Closest Location: Washington State University College of Pharmacy and Pharmaceutical Sciences · Spokane, WA
2021First Recorded Clinical Trial
1 TrialsResearching Interactions
2 CompletedClinical Trials
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,393 Previous Clinical Trials
24,523,938 Total Patients Enrolled
Washington State UniversityLead Sponsor
83 Previous Clinical Trials
55,547 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,789 Previous Clinical Trials
2,223,517 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are taking no medications or dietary supplements that can interfere with your ability to eliminate the study drugs from your body.
You are willing to stop taking dietary/herbal supplements and citrus juices for several weeks.
You 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.
You have the time to participate.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- 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.
- US Food and Drug Administration. Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions.
- 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.
- 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.
- 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.
- Feng, Bo, and Manthena V. Varma. 2016. “Evaluation and Quantitative Prediction of Renal Transporter-mediated Drug-drug Interactions”. The Journal of Clinical Pharmacology. Wiley. doi:10.1002/jcph.702.
- 2022. "Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05365451.
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