Effect of a Proton Pump Inhibitor (Omeprazole, Prilosec®) on Imatinib Mesylate (Gleevec®) Pharmacokinetics in Healthy Volunteers (CSTI571BUS258)
This is an open-label, single-institution, randomized cross-over, fixed schedule study of
the effects of proton pump inhibitors (PPI) 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 PPI (Prilosec® Delayed-Release Capsules).
Gleevec® will be administered at a dose of 400 mg, and the PPI (Prilosec®) at a dose level
of 40 mg daily for 6 consecutive days. Half of the subjects will receive Prilosec® starting
5 days before Day 1 through Day 1 along with Gleevec® on Day 1, and Gleevec® alone on Day
15. The other half will receive Prilosec® on Days 10-15, along with Gleevec® on Day 15, and
Gleevec® alone on Day 1. On days that both drugs are administered, the Prilosec® will be
administered 15 minutes before the Gleevec® dose.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the effect of omeprazole administration on the pharmacokinetics (in particular the area under the Gleevec® plasma concentration versus time curve) of 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, 12, 24, 48, and 72 hrs after adminstration of Gleevec®.
Jan H. Beumer, PharmD, PhD
University of Pittsburgh
United States: Institutional Review Board
|University of Pittsburgh Cancer Institute / Clinical and Translational Research Center (Hillman Cancer Center and Montefiore University Hospital locations)||Pittsburgh, Pennsylvania 15232 / 15213|