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

Novartis Pharmaceuticals16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

imatinibDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib

Secondary Outcomes

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

Data from ClinicalTrials.gov

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