Overview

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

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Novartis
Treatments:
Imatinib Mesylate
Omeprazole
Proton Pump Inhibitors
Criteria
Inclusion Criteria:

- Healthy men or women 18 years of age or older. Healthy subjects are defined as
individuals who are free from clinically significant illness or disease (such as
coronary arterial disease, chronic heart failure, bleeding disorder, hypertension,
chronic renal failure etc.) as determined by their medical history, physical
examination, and laboratory studies.

- Body Mass Index (BMI) < 31 kg/m^2 (weight/height^2).

- Female subjects of childbearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Male and female
subjects of reproductive potential must agree to employ an effective barrier method of
birth control throughout the study and for up to 7 days following discontinuation of
study drug.

- Written, voluntary informed consent.

- Subjects participating in the protocol entitled "IRB: 0701014: Effect of Antacids
(Mg-Al-based) on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers
(CSTI571BUS257) (UPCI #06-088)" will be eligible for participation in this study
provided they meet all other eligibility criteria for this study.

Exclusion Criteria:

- Abnormal marrow function as defined by leucocyte, neutrophil, or platelet counts
outside of normal limits.

- Any evidence of renal dysfunction (proteinuria; serum creatinine > upper limit of
normal; or if serum creatinine > upper limit of normal, a calculated creatinine
clearance < 60 mL/min/1.73 m2).

- Impaired hepatic function (liver enzymes greater than the upper limit of normal or
bilirubin outside the normal range).

- Taking any medications (including over the counter products), herbal products, mineral
supplements or vitamins (other than a daily multivitamin preparation), other than
contraceptives (for women), within 2 weeks of start of the study. All forms of
contraceptive medication are permissible for this study and would not result in a
female's exclusion from participation. Patients who take medications on a chronic
basis, such as antihypertensive medications or thyroid replacement therapy, etc. are
not eligible for the study.

- Subjects that have received any other investigational agents within 28 days of first
day of study drug dosing.

- Female subjects who are pregnant or breast-feeding.