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NCT00446316 · ClinicalTrials.gov registry record · Phase 1
Effect of Antacids on Gleevec® in Healthy Volunteers
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00446316 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 12 participants.
The verdict
NCT00446316, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a research study that will investigate the effects of antacids (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 antacids. Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. One one occasion they will take the dose of Gleevec® alone. On another occasion, they will take the Gleevec® 15 minutes after taking a 20 mL dose of antacids. 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 antacids.
Interventions
- DRUG Antacids (Mg-Al-based)
- DRUG Imatimib Mesylate (Gleevec®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00446316
The ClinicalTrials.gov registry entry for NCT00446316 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 Antacids (Mg-Al-based) is the first listed.
NCT00446316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00446316 about?
NCT00446316 is a clinical study titled "Effect of Antacids on Gleevec® in Healthy Volunteers". This is a research study that will investigate the effects of antacids (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 re...
What is the current status of trial NCT00446316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-04. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00446316?
The interventions under investigation include: Antacids (Mg-Al-based) (DRUG), Imatimib Mesylate (Gleevec®) (DRUG).
Who is sponsoring clinical trial NCT00446316?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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