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
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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®.
Jan H. Beumer, PharmD, PhD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center location)||Pittsburgh, Pennsylvania 15232|