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

Study Overview
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Brief Summary
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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
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: imatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib 800mg<br> | Drug: imatinib<br> <br> |
| Active Comparator: Imatinib 400mg<br> | Drug: imatinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, Food effect, bioavailability, pharmacokinetic, imatinib, STI571, modified release formulation of STI571, Chronic Myeloid Leukemia, Philadelphia Chromosome