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Effect of Calcium Supplements on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS 280) (UPCI 08-072)

18 Years
Open (Enrolling)

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Trial Information

Effect of Calcium Supplements on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS 280) (UPCI 08-072)

This is an open-label, single-institution, randomized cross-over, fixed-schedule
investigation of the effects of calcium carbonate on the pharmacokinetics (PK) of Gleevec®
in healthy volunteers. Healthy volunteers will be recruited to participate in this study
such that twelve subjects (6 men / 6 women) will complete the study at UPCI. Subjects will
be compensated for participation.

Half of the subjects will receive Gleevec® alone on Day 1 and Gleevec® and calcium carbonate
on Day 15, and the other half will receive Gleevec® and calcium carbonate on Day 1 and
Gleevec® alone on Day 15, determined by randomization of subjects receiving either the
combination or Gleevec® alone during the first visit. Doses will be 400 mg Gleevec® and 4000
mg calcium carbonate (4 x Tums Ultra 1000® chewable tablets, equivalent to 4000 mg calcium
carbonate or 1600 mg calcium.

Multiple PK blood samples will be taken from Days 1-4 and Days 15-18. Gleevec® PKwill be
assessed after oral administration of 400 mg Gleevec® alone, and after oral administration
of 400 mg Gleevec® with concomitant administration of 4000 mg calcium carbonate. Two 10-hour
outpatient dosing visits and six brief outpatient visits are required to accommodate all
study procedures.

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. For the purposes of this protocol, "clinically
significant" is defined as any history or indication of illness or disease, such as
those listed above.

- Body Mass Index (BMI) < 31 kg/m2 (weight/height2).

- Female patients of childbearing potential must have negative pregnancy test within 14
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Female
patients 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.

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 has 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 administration of a calcium salt (calcium carbonate) on the PK (in particular the area under the imatinib plasma concentration versus time curve) of imatinib (Gleevec®) in healthy volunteers.

Outcome Time Frame:

PK blood samples are drawn from each subject at time 0 (before each dose of Gleevec®), and at 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 48, and 72 hrs after adminstration of Gleevec®.

Safety Issue:


Principal Investigator

Jan H. Beumer, PharmD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

December 2012

Related Keywords:

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



University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center location)Pittsburgh, Pennsylvania  15232