Status:
COMPLETED
Effect of Antacids on Gleevec® in Healthy Volunteers
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Novartis
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is an open-label, single-institution, randomized cross-over, fixed schedule study of the effects of Mg-Al-based antacids on Imatinib Mesylate (Gleevec®) pharmacokinetics. Healthy volunteers will ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00446316
Start Date
April 1 2007
End Date
October 1 2008
Last Update
June 22 2016
Active Locations (1)
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1
University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)
Pittsburgh, Pennsylvania, United States, 15232 / 15213