Trial · NCT05365451

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

NCT05365451, Early phase 1, Completed, Washington State University; results first posted 2025-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters. Trials, record NCT05365451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05365451

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters
NCT number: NCT05365451
Status: Completed
Phases: Early phase 1
Enrollment: 16 participants, actual
Lead sponsor: Washington State University
Conditions: Interaction, Endogenous Biomarkers
Interventions: MetFORMIN Oral Solution, Cimetidine 400 MG, Furosemide Oral Liquid Product, Probenecid 500 MG
First posted: 2022-05-09
Last updated: 2025-08-08
Results first posted: 2025-08-08

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Metformin Area Under the Concentration vs. Time Curve (AUC)	0-24 hours	baseline metformin area under the concentration vs. time curve (AUC)
Primary	Metformin AUC in Presence of Cimetidine	0-24 hours	Metformin area under the concentration vs. time curve (AUC) in presence of cimetidine
Primary	Metformin Maximum Concentration (Cmax)	0-24 hours	baseline metformin maximum concentration (Cmax)
Primary	Metformin Cmax in Presence of Cimetidine	0-24 hours	metformin Cmax in the presence of cimetidine
Primary	Metformin Renal Clearance (CLr)	0-24 hours	baseline metformin renal clearance (CLr)
Primary	Metformin CLr in Presence of Cimetidine	0-24 hours	metformin CLr in the presence of cimetidine
Primary	Furosemide Area Under the Concentration vs. Time Curve (AUC)	0-24 hours	baseline furosemide area under the concentration vs. time curve (AUC)
Primary	Furosemide AUC in Presence of Probenecid	0-24 hours	furosemide AUC in the presence of probenecid
Primary	Furosemide Renal Clearance (CLr)	0-24 hours	baseline furosemide renal clearance (CLr)
Primary	Furosemide CLr in Presence of Probenecid	0-24 hours	furosemide CLr in the presence of probenecid

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Metformin Area Under the Concentration vs. Time Curve (AUC)	0-24 hours	mcg*h/L	GEOMETRIC_MEAN
PRIMARY	Metformin AUC in Presence of Cimetidine	0-24 hours	mcg*h/L	GEOMETRIC_MEAN
PRIMARY	Metformin Maximum Concentration (Cmax)	0-24 hours	mcg/L	GEOMETRIC_MEAN
PRIMARY	Metformin Cmax in Presence of Cimetidine	0-24 hours	mcg/L	GEOMETRIC_MEAN
PRIMARY	Metformin Renal Clearance (CLr)	0-24 hours	L/h	GEOMETRIC_MEAN
PRIMARY	Metformin CLr in Presence of Cimetidine	0-24 hours	L/h	GEOMETRIC_MEAN
PRIMARY	Furosemide Area Under the Concentration vs. Time Curve (AUC)	0-24 hours	ng.h/mL	GEOMETRIC_MEAN
PRIMARY	Furosemide AUC in Presence of Probenecid	0-24 hours	ng.h/mL	GEOMETRIC_MEAN
PRIMARY	Furosemide Renal Clearance (CLr)	0-24 hours	mL/min	GEOMETRIC_MEAN
PRIMARY	Furosemide CLr in Presence of Probenecid	0-24 hours	mL/min	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Metformin Area Under the Concentration vs. Time Curve (AUC)	Arm 1A - Arm 2A - Arm 1B - Arm 2B	830	90% Confidence Interval 710 to 970	mcg*h/L
Metformin AUC in Presence of Cimetidine	Arm 1A - Arm 2A - Arm 1B - Arm 2B	1030	90% Confidence Interval 875 to 1210	mcg*h/L
Metformin Maximum Concentration (Cmax)	Arm 1A - Arm 2A - Arm 1B - Arm 2B	124	90% Confidence Interval 107 to 143	mcg/L
Metformin Cmax in Presence of Cimetidine	Arm 1A - Arm 2A - Arm 1B - Arm 2B	168	90% Confidence Interval 145 to 195	mcg/L
Metformin Renal Clearance (CLr)	Arm 1A - Arm 2A - Arm 1B - Arm 2B	31	90% Confidence Interval 27 to 34	L/h
Metformin CLr in Presence of Cimetidine	Arm 1A - Arm 2A - Arm 1B - Arm 2B	28	90% Confidence Interval 25 to 31	L/h
Furosemide Area Under the Concentration vs. Time Curve (AUC)	Arm 1A - Arm 2A - Arm 1B - Arm 2B	462.4	90% Confidence Interval 338.3 to 586.5	ng.h/mL
Furosemide AUC in Presence of Probenecid	Arm 1A - Arm 2A - Arm 1B - Arm 2B	854.6	90% Confidence Interval 608.5 to 1100.7	ng.h/mL
Furosemide Renal Clearance (CLr)	Arm 1A - Arm 2A - Arm 1B - Arm 2B	96.1	90% Confidence Interval 68.7 to 123.5	mL/min
Furosemide CLr in Presence of Probenecid	Arm 1A - Arm 2A - Arm 1B - Arm 2B	33.4	90% Confidence Interval 24.2 to 42.6	mL/min

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin Alone, Then Cimetidine + Metformin, Then Furosemide Alone, Then Probenecid + Furosemide	16
Overall Study	COMPLETED	Metformin Alone, Then Cimetidine + Metformin, Then Furosemide Alone, Then Probenecid + Furosemide	16
Overall Study	NOT COMPLETED	Metformin Alone, Then Cimetidine + Metformin, Then Furosemide Alone, Then Probenecid + Furosemide	0

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Metformin Alone	1	16	1
other	Headache	Nervous system disorders	Cimetidine + Metformin	0	16	0
other	Headache	Nervous system disorders	Furosemide Alone	2	16	2
other	Headache	Nervous system disorders	Probenecid + Furosemide	3	16	3
other	nausea/vomiting	Nervous system disorders	Metformin Alone	0	16	0
other	nausea/vomiting	Nervous system disorders	Cimetidine + Metformin	0	16	0
other	nausea/vomiting	Nervous system disorders	Furosemide Alone	0	16	0
other	nausea/vomiting	Nervous system disorders	Probenecid + Furosemide	1	16	1
other	IV site tenderness	Skin and subcutaneous tissue disorders	Metformin Alone	0	16	0
other	IV site tenderness	Skin and subcutaneous tissue disorders	Cimetidine + Metformin	0	16	0

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin Alone	0	16
Total, all-cause mortality	Cimetidine + Metformin	0	16
Total, all-cause mortality	Furosemide Alone	0	16
Total, all-cause mortality	Probenecid + Furosemide	0	16
Total, other adverse events	Metformin Alone	1	16
Total, other adverse events	Cimetidine + Metformin	1	16
Total, other adverse events	Furosemide Alone	3	16
Total, other adverse events	Probenecid + Furosemide	4	16
Total, serious adverse events	Metformin Alone	0	16
Total, serious adverse events	Cimetidine + Metformin	0	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23140242	BACKGROUND	PubMed
27385169	BACKGROUND	PubMed
30361237	BACKGROUND	PubMed
31511257	BACKGROUND	PubMed
33256492	BACKGROUND	PubMed
40401788	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD081299	Ontogeny of drug transport	PRASAD, BHAGWAT	CINCINNATI CHILDRENS HOSP MED CTR	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2015 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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