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

Condition(s) targeted: Healthy

Intervention: imatinib (Drug)

Phase: Phase 1

Status: Completed

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

Secondary outcome:

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. Gender(s): Both.

Criteria:

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.

Starting date: June 2006
Last updated: January 16, 2007