Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imatinib 800mg
- interventionNames
- Drug: imatinib
- type
- ACTIVE_COMPARATOR
- label
- Imatinib 400mg
- interventionNames
- Drug: imatinib
Primary outcomes (1)
- measure
- Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib
Secondary outcomes (2)
- measure
- To compare safety and tolerability of 800 mg modified release formulation with or without food.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available