Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

A Phase I, Two Arm, Open-label, Randomized, Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in Modified Release Formulations (MR3 and MR4) and Compare the Bioavailability Between MR3, MR4 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

NCT00420043

Enrollment

Registered

2007-01-09

Start date

2006-09-30

Completion date

2006-11-30

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, STI571, modified release formulation of STI571, CML, Chronic Myeloid Leukemia, Philadelphia Chromosome, imatinib

Brief summary

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.

Interventions

DRUGimatinib

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Outcome results

None listed

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