Effect of Antacids on Gleevec® in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Healthy
Interventions
DRUG

Antacids (Mg-Al-based)

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).

DRUG

Imatimib Mesylate (Gleevec®)

Gleevec® will be administered at a dose of 400 mg. 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.

Trial Locations (1)

15232 / 15213

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

University of Pittsburgh

OTHER