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

NCT00446004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-06-22

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Imatinib Mesylate

Dosage form: tablets Dosage: 400 mg Frequency \& duration: On an 18-day schedule, one dose administered once on day 1 and once on day 15 (2 doses total)

DRUG

Omeprazole

Dosage form: capsules Dosage: 40 mg Frequency: On an 18-day schedule, once daily day 10 through day 16 (for Arm A); or once daily day -4 through day 1 (for Arm B)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Jan H. Beumer, PharmD, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446004 on ClinicalTrials.gov