Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00446004
Brief 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.
Detailed Description:
This is an open-label, single-institution, randomized cross-over, fixed schedule study of the effects of proton pump inhibitors (PPI) on Imatinib Mesylate (Gleevec®) pharmacokinetics. Healthy volunteers will be recruited to participate in this study such that twelve subjects (6 men / 6 women) will complete the study. Gleevec® pharmacokinetics will be assessed after oral administration of Gleevec® and after oral administration of Gleevec® with concomitant administration of PPI (Prilosec® Delayed-Release Capsules). Gleevec® will be administered at a dose of 400 mg, and the PPI (Prilosec®) at a dose level of 40 mg daily for 6 consecutive days. Half of the subjects will receive Prilosec® starting 5 days before Day 1 through Day 1 along with Gleevec® on Day 1, and Gleevec® alone on Day 15. The other half will receive Prilosec® on Days 10-15, along with Gleevec® on Day 15, and Gleevec® alone on Day 1. On days that both drugs are administered, the Prilosec® will be administered 15 minutes before the Gleevec® dose.
Study:
NCT00446004
Study Brief:
Protocol Section:
NCT00446004