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.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Jan H. Beumer, Pharm.D., Ph.D.
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|