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NCT00446004 · ClinicalTrials.gov registry record · Phase 1

Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers

A Phase 1 study, sponsored by University of Pittsburgh.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00446004 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 15 participants.

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The verdict

NCT00446004, a Phase 1 study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

This is a research study that will investigate the effects of proton pump inhibitors (often used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to complete the study. This research study will compare Gleevec® in the body when taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI daily by mouth for six days. Several blood samples will be drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with and without the influence of PPI.

Interventions

  • DRUG Omeprazole
  • DRUG Imatinib Mesylate

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2007-04
Est. Completion 2009-08
Phase Phase 1

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT00446004

The ClinicalTrials.gov registry entry for NCT00446004 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

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

NCT00446004 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00446004 about?

NCT00446004 is a clinical study titled "Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers". This is a research study that will investigate the effects of proton pump inhibitors (often used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to complete the ...

What is the current status of trial NCT00446004?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2007-04. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00446004?

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

Who is sponsoring clinical trial NCT00446004?

This trial is sponsored by University of Pittsburgh, which has 1,238 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.