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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: Completed Phase 1 study, sponsored by University of Pittsburgh.
NCT00446004 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00446004 record still lists
NCT00446004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Omeprazole is the first listed.
NCT00446004 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00446004's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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