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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422825

Enrollment

Registered

2007-01-17

Start date

2006-06-30

Completion date

2006-09-30

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Food effect, bioavailability, pharmacokinetic, imatinib, STI571, modified release formulation of STI571, CML, Chronic Myeloid Leukemia, Philadelphia Chromosome

Brief summary

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

Interventions

DRUGimatinib

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026