Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: imatinib (Drug)
Phase: Phase 1
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
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
Official title: 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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
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
Minimum age: 40 Years.
Maximum age: 65 Years.
- Healthy male or female subjects (postmenopausal women)
- Able to communicate well with the investigator and comply with the requirements of the
- 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
- 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
- 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
Locations and Contacts
Starting date: June 2006
Last updated: January 16, 2007