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NCT01404715 · ClinicalTrials.gov registry record · Phase 1

Drug-drug Interaction Study With Metformin and Imatinib

A Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target

NCT01404715 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 11 participants.

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The verdict

NCT01404715, a Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study Summary

This study will address the following question: Does imatinib influence the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that imatinib may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. 1. The investigators hypothesize that the addition of imatinib to metformin therapy will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and risk for toxicities 2. Knowledge of the pharmacokinetic interaction profile of metformin with organic cation transporter inhibitors, such as imatinib, is important to help develop safer more effective drug therapy with reduced side effects.

Interventions

  • DRUG Metformin
  • DRUG Imatinib

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2011-10
Est. Completion 2013-03
Phase Phase 1

What the Registry Record Tells You About NCT01404715

The ClinicalTrials.gov registry entry for NCT01404715 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.

NCT01404715 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01404715 about?

NCT01404715 is a clinical study titled "Drug-drug Interaction Study With Metformin and Imatinib". This study will address the following question: Does imatinib influence the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that imatinib may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of ...

What is the current status of trial NCT01404715?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2011-10. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01404715?

The interventions under investigation include: Metformin (DRUG), Imatinib (DRUG).

Who is sponsoring clinical trial NCT01404715?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.