Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

Phase 1CompletedNCT00420043

Novartis32 enrolled

Overview

This study will evaluate the effect of food on the relative bioavailability of a single dose of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400 mg film-coated tablets. There will be a 8 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: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria * Healthy male or female subjects (postmenopausal women), 18-65 years of age * Able to communicate well with the investigator and comply with the requirements of the study. Exclusion criteria * Smokers within 3 months * Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 3 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 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

To compare the bioavailability of Modified Release formulations to 400 mg immediate release (IR) tablet when administered twice-daily (both given with a low fat meal).

Secondary Outcomes

To compare the relative bioavailability of a single daily 800 mg dose of modified release formulations with a high fat meal and a low fat (regular) meal, to modified release formulations after over-night fasting in healthy volunteers.

To compare safety and tolerability of the 800 mg daily dose modified release formulations with or without food

Data from ClinicalTrials.gov

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