Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib

A Phase I, Open-label, Randomized, Crossover Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in a Modified Release Formulation (MR2) and Compare the Bioavailability Between MR2 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects

This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments

Inclusion criteria

• Healthy male or female subjects (postmenopausal women)
• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

• Smokers
• Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 2 weeks prior to dosing.
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
• A past medical history or presence of clinically significant ECG abnormalities including:
• History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
• History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
• Women taking any biphosphonates (Fosomax like drugs)
• History of being immunocompromised, including a positive HIV test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.