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Effect of Antacids (Mg-Al-based) on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS257)

18 Years
65 Years
Not Enrolling

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Trial Information

Effect of Antacids (Mg-Al-based) on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS257)

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 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 magnesium-aluminum hydroxide-based antacid (Maalox). Gleevec® will be
administered at a dose of 400 mg, and the antacid (Maximum Strength Maalox®Max®
Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and
1600 mg magnesium hydroxide). Half of the subjects will receive Gleevec® and antacid on day
15 and Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they
will receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15.
The antacids will be administered 15 minutes before the Gleevec® dose.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the effect of antacid administration on the pharmacokinetics (in particular the area under the Gleevec® plasma concentration versus time curve) of Gleevec® in healthy volunteers.

Outcome Time Frame:

15 days

Safety Issue:


Principal Investigator

Jan H. Beumer, Pharm.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

October 2008

Related Keywords:

  • Healthy
  • Pharmacokinetics
  • Healthy volunteers
  • No condition
  • Pharmacokinetics study



University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)Pittsburgh, Pennsylvania  15232 / 15213