Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

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.

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Key information

Conditions

Healthy Bone Marrow Diseases Chromosome Aberrations Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Philadelphia Chromosome Translocation, Genetic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imatinib

Drug

Other names: STI571

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Jan 9, 2007
Registry last updated: Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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