Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
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
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
Secondary Outcome Measures
To compare safety and tolerability of 800 mg modified release formulation with or without food.
To compare the relative bioavailability of a single dose 800 mg modified release formulation (with a low fat breakfast) with the marketed 400 mg immediate release tablet administered (with a low fat breakfast) twice daily
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
40 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male or female subjects (postmenopausal women)
Able to communicate well with the investigator and comply with the requirements of the study.
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.