InteractionEarly Phase 1NCT05365451
Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters
A Early Phase 1 study testing MetFORMIN Oral Solution, Cimetidine 400 MG and Furosemide Oral Liquid Product in people with Interaction and Endogenous Biomarkers, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interaction, Endogenous Biomarkers
- What is being tested?
- MetFORMIN Oral Solution, Cimetidine 400 MG and Furosemide Oral Liquid Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 22 Jul 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, 99202
About this study
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.
Read the detailed description
The kidneys are major organs responsible for the excretion of both endogenous and exogenous compounds, the latter including drugs and other xenobiotics. Excretion occurs via passive or active processes, the latter involving transporters such as organic cation transporters (OCTs) and organic anion transporters (OATs). Inhibition of these transporters, coupled with the large interindividual variability in transporter expression, can lead to toxic accumulation of compounds/xenobiotics cleared primarily by this route. During drug discovery and development, if in vitro evidence suggests renal transporters mediate excretion of a new chemical entity, the Food and Drug Administration recommends conducting a controlled clinical study to evaluate potential risks. These time-consuming and expensive clinical studies routinely involve adult participants and known substrates of renal transporters. However, such studies are not always feasible in children due to the enhanced potential for toxicities. This limitation led to the hypothesis that endogenous substrates could be used as surrogates, or biomarkers, of individual renal transporter function.
Endogenous OCT substrates, such as 1-methyladenosine (m1A) and 1-methylnicotinamide (MNA), as well as OATs, such as homovanillic acid (HVA) and pyridoxic acid (PDA), are promising biomarkers of renal transporters in adults. However, using one or few such endogenous substrates can be misleading due to factors other than variability in specific renal transporter function. We propose to address this knowledge gap by using a panel of endogenous substrates/metabolites that recently has been identified as a robust biomarker of rodent Octs and Oats. Validation of these substrates/metabolites as biomarkers of OCTs and OATs in humans, both adults and children, will aid in the development of physiologically-based pharmacokinetic models that can be used to predict renal transporter-mediated xenobiotic excretion, drug-drug interactions, and toxicity in children.
- Conditions
- Interaction, Endogenous Biomarkers
- Being tested
- MetFORMIN Oral Solution, Cimetidine 400 MG, Furosemide Oral Liquid Product, Probenecid 500 MG
- Keywords
- Kidney Transporter, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetFORMIN Oral SolutionDrug
Also called Riomet
liquid
Cimetidine 400 MGDrug
Also called Tagamet
tablet
Furosemide Oral Liquid ProductDrug
Also called Lasix
oral solution
Probenecid 500 MGDrug
Also called Probalan
tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A: metformin alone (baseline) | Experimental | 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. Receives: Drug: MetFORMIN Oral Solution |
| Arm 1B: metformin + cimetidine | Experimental | 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. Receives: Drug: MetFORMIN Oral Solution; Drug: Cimetidine 400 MG |
| Arm 2A: furosemide alone (baseline) | Experimental | 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. Receives: Drug: Furosemide Oral Liquid Product |
| Arm 2B: furosemide + probenecid | Experimental | 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. Receives: Drug: Furosemide Oral Liquid Product; Drug: Probenecid 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin Area Under the Concentration vs. Time Curve (AUC)
baseline metformin area under the concentration vs. time curve (AUC)
Measured: 0-24 hours
Metformin AUC in Presence of Cimetidine
Metformin area under the concentration vs. time curve (AUC) in presence of cimetidine
Measured: 0-24 hours
Metformin Maximum Concentration (Cmax)
baseline metformin maximum concentration (Cmax)
Measured: 0-24 hours
Metformin Cmax in Presence of Cimetidine
metformin Cmax in the presence of cimetidine
Measured: 0-24 hours
Metformin Renal Clearance (CLr)
baseline metformin renal clearance (CLr)
Measured: 0-24 hours
Metformin CLr in Presence of Cimetidine
metformin CLr in the presence of cimetidine
Measured: 0-24 hours
Furosemide Area Under the Concentration vs. Time Curve (AUC)
baseline furosemide area under the concentration vs. time curve (AUC)
Measured: 0-24 hours
Furosemide AUC in Presence of Probenecid
furosemide AUC in the presence of probenecid
Measured: 0-24 hours
Furosemide Renal Clearance (CLr)
baseline furosemide renal clearance (CLr)
Measured: 0-24 hours
Furosemide CLr in Presence of Probenecid
furosemide CLr in the presence of probenecid
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start11 Apr 2022
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Mary Paine, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365451
- Sponsor's protocol ID
- 19163
- Other IDs
- R01HD081299
- Status last verified
- Aug 2025
- First submitted
- 4 May 2022
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morrissey KM, Stocker SL, Wittwer MB, Xu L, Giacomini KM. Renal transporters in drug development. Annu Rev Pharmacol Toxicol. 2013;53:503-29. doi: 10.1146/annurev-pharmtox-011112-140317. Epub 2012 Nov 8.
PubMed 23140242US 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 H, Holenarsipur VK, Mariappan TT, Drexler DM, Cantone JL, Rajanna P, Singh Gautam S, Zhang Y, Gan J, Shipkova PA, Marathe P, Humphreys WG. Evidence for the Validity of Pyridoxic Acid (PDA) as a Plasma-Based Endogenous Probe for OAT1 and OAT3 Function in Healthy Subjects. J Pharmacol Exp Ther. 2019 Jan;368(1):136-145. doi: 10.1124/jpet.118.252643. Epub 2018 Oct 25.
PubMed 30361237Miyake T, Mizuno T, Takehara I, Mochizuki T, Kimura M, Matsuki S, Irie S, Watanabe N, Kato Y, Ieiri I, Maeda K, Ando O, Kusuhara H. Elucidation of N 1-methyladenosine as a Potential Surrogate Biomarker for Drug Interaction Studies Involving Renal Organic Cation Transporters. Drug Metab Dispos. 2019 Nov;47(11):1270-1280. doi: 10.1124/dmd.119.087262. Epub 2019 Sep 11.
PubMed 31511257Naji-Talakar S, Sharma S, Martin LA, Barnhart D, Prasad B. Potential implications of DMET ontogeny on the disposition of commonly prescribed drugs in neonatal and pediatric intensive care units. Expert Opin Drug Metab Toxicol. 2021 Mar;17(3):273-289. doi: 10.1080/17425255.2021.1858051. Epub 2021 Jan 20.
PubMed 33256492Feng B, Varma MV. Evaluation and Quantitative Prediction of Renal Transporter-Mediated Drug-Drug Interactions. J Clin Pharmacol. 2016 Jul;56 Suppl 7:S110-21. doi: 10.1002/jcph.702.
PubMed 27385169Thakur A, Singh DK, Hart KD, Kis E, Gaborik Z, Denton TT, Clarke JD, Paine MF, Prasad B. From Discovery to Translation: Endogenous Substrates of OAT1 and OAT3 as Clinical Biomarkers for Renal Secretory Function. Clin Pharmacol Ther. 2025 Sep;118(3):693-704. doi: 10.1002/cpt.3719. Epub 2025 May 22.
PubMed 40401788
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters
- ClinicalTrials.gov ID
- NCT05365451
- Acronym / sponsor ID
- 19163
- Conditions
- Interaction, Endogenous Biomarkers
- Keywords
- Kidney Transporter, Pharmacokinetics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The kidneys are major organs responsible for the excretion of both endogenous and exogenous compounds, the latter including drugs and other xenobiotics. Excretion occurs via passive or active processes, the latter involving transporters such as organic cation transporters (OCTs) and organic anion transporters (OATs). Inhibition of these transporters, coupled with the large interindividual variability in transporter expression, can lead to toxic accumulation of compounds/xenobiotics cleared primarily by this route. During drug discovery and development, if in vitro evidence suggests renal transporters mediate excretion of a new chemical entity, the Food and Drug Administration recommends conducting a controlled clinical study to evaluate potential risks. These time-consuming and expensive clinical studies routinely involve adult participants and known substrates of renal transporters. However, such studies are not always feasible in children due to the enhanced potential for toxicities. This limitation led to the hypothesis that endogenous substrates could be used as surrogates, or biomarkers, of individual renal transporter function.
Endogenous OCT substrates, such as 1-methyladenosine (m1A) and 1-methylnicotinamide (MNA), as well as OATs, such as homovanillic acid (HVA) and pyridoxic acid (PDA), are promising biomarkers of renal transporters in adults. However, using one or few such endogenous substrates can be misleading due to factors other than variability in specific renal transporter function. We propose to address this knowledge gap by using a panel of endogenous substrates/metabolites that recently has been identified as a robust biomarker of rodent Octs and Oats. Validation of these substrates/metabolites as biomarkers of OCTs and OATs in humans, both adults and children, will aid in the development of physiologically-based pharmacokinetic models that can be used to predict renal transporter-mediated xenobiotic excretion, drug-drug interactions, and toxicity in children.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1A: metformin alone (baseline) | Experimental | Drug: MetFORMIN Oral SolutionArm 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. |
| Arm 1B: metformin + cimetidine | Experimental | Drug: MetFORMIN Oral Solution, Drug: Cimetidine 400 MGArm 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. |
| Arm 2A: furosemide alone (baseline) | Experimental | Drug: Furosemide Oral Liquid ProductArm 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. |
| Arm 2B: furosemide + probenecid | Experimental | Drug: Furosemide Oral Liquid Product, Drug: Probenecid 500 MGArm 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetFORMIN Oral SolutionAlso: Riometliquid | Drug | Arm 1A: metformin alone (baseline), Arm 1B: metformin + cimetidine |
| Cimetidine 400 MGAlso: Tagamettablet | Drug | Arm 1B: metformin + cimetidine |
| Furosemide Oral Liquid ProductAlso: Lasixoral solution | Drug | Arm 2A: furosemide alone (baseline), Arm 2B: furosemide + probenecid |
| Probenecid 500 MGAlso: Probalantablet | Drug | Arm 2B: furosemide + probenecid |
Primary outcome
Metformin Area Under the Concentration vs. Time Curve (AUC)
Time frame: 0-24 hours
baseline metformin area under the concentration vs. time curve (AUC)
Metformin AUC in Presence of Cimetidine
Time frame: 0-24 hours
Metformin area under the concentration vs. time curve (AUC) in presence of cimetidine
Metformin Maximum Concentration (Cmax)
Time frame: 0-24 hours
baseline metformin maximum concentration (Cmax)
Metformin Cmax in Presence of Cimetidine
Time frame: 0-24 hours
metformin Cmax in the presence of cimetidine
Metformin Renal Clearance (CLr)
Time frame: 0-24 hours
baseline metformin renal clearance (CLr)
Metformin CLr in Presence of Cimetidine
Time frame: 0-24 hours
metformin CLr in the presence of cimetidine
Furosemide Area Under the Concentration vs. Time Curve (AUC)
Time frame: 0-24 hours
baseline furosemide area under the concentration vs. time curve (AUC)
Furosemide AUC in Presence of Probenecid
Time frame: 0-24 hours
furosemide AUC in the presence of probenecid
Furosemide Renal Clearance (CLr)
Time frame: 0-24 hours
baseline furosemide renal clearance (CLr)
Furosemide CLr in Presence of Probenecid
Time frame: 0-24 hours
furosemide CLr in the presence of probenecid
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23140242Morrissey KM, Stocker SL, Wittwer MB, Xu L, Giacomini KM. Renal transporters in drug development. Annu Rev Pharmacol Toxicol. 2013;53:503-29. doi: 10.1146/annurev-pharmtox-011112-140317. Epub 2012 Nov 8.
- BackgroundUS 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.
- Background: PubMed 30361237Shen H, Holenarsipur VK, Mariappan TT, Drexler DM, Cantone JL, Rajanna P, Singh Gautam S, Zhang Y, Gan J, Shipkova PA, Marathe P, Humphreys WG. Evidence for the Validity of Pyridoxic Acid (PDA) as a Plasma-Based Endogenous Probe for OAT1 and OAT3 Function in Healthy Subjects. J Pharmacol Exp Ther. 2019 Jan;368(1):136-145. doi: 10.1124/jpet.118.252643. Epub 2018 Oct 25.
- Background: PubMed 31511257Miyake T, Mizuno T, Takehara I, Mochizuki T, Kimura M, Matsuki S, Irie S, Watanabe N, Kato Y, Ieiri I, Maeda K, Ando O, Kusuhara H. Elucidation of N 1-methyladenosine as a Potential Surrogate Biomarker for Drug Interaction Studies Involving Renal Organic Cation Transporters. Drug Metab Dispos. 2019 Nov;47(11):1270-1280. doi: 10.1124/dmd.119.087262. Epub 2019 Sep 11.
- Background: PubMed 33256492Naji-Talakar S, Sharma S, Martin LA, Barnhart D, Prasad B. Potential implications of DMET ontogeny on the disposition of commonly prescribed drugs in neonatal and pediatric intensive care units. Expert Opin Drug Metab Toxicol. 2021 Mar;17(3):273-289. doi: 10.1080/17425255.2021.1858051. Epub 2021 Jan 20.
- Background: PubMed 27385169Feng B, Varma MV. Evaluation and Quantitative Prediction of Renal Transporter-Mediated Drug-Drug Interactions. J Clin Pharmacol. 2016 Jul;56 Suppl 7:S110-21. doi: 10.1002/jcph.702.
- Derived from this study: PubMed 40401788Thakur A, Singh DK, Hart KD, Kis E, Gaborik Z, Denton TT, Clarke JD, Paine MF, Prasad B. From Discovery to Translation: Endogenous Substrates of OAT1 and OAT3 as Clinical Biomarkers for Renal Secretory Function. Clin Pharmacol Ther. 2025 Sep;118(3):693-704. doi: 10.1002/cpt.3719. Epub 2025 May 22.
- Individual participant dataSharing planned: No
Related trials for Interaction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
RecruitingObservational study
Molecular Basis of Human Phagocyte Interactions With Bacterial Pathogens
Host Defense Mechanisms
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MetFORMIN Oral Solution, Cimetidine 400 MG and Furosemide Oral Liquid Product in people with Interaction and Endogenous Biomarkers, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metformin Area Under the Concentration vs. Time Curve (AUC) (time frame: 0-24 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365451, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.