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

ClinicalTrials.gov ID: NCT00446004

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Official title

Effect of a Proton Pump Inhibitor (Omeprazole, Prilosec®) on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS258)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00446004
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: University of Pittsburgh; Other
Enrollment: 15 participants

Conditions and interventions

Conditions

Healthy

Interventions

Imatinib Mesylate Drug
Omeprazole Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2007 (Type not available)
Primary completion: Aug 2009 (Actual)
Completion: Aug 2009 (Actual)
Last update posted: Jun 22, 2016

2007 – 2009

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)	Pittsburgh	Pennsylvania	15232 / 15213	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00446004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 22, 2016 · Synced Nov 11, 2026