Effect of Food on Bioavailability of Modified Release Formulations of Imatinib - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00420043

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: imatinib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Official 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

Resource links provided by NLM:

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	32
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420043

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CSTI571O 2103
Study First Received:	January 8, 2007
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00420043 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Food effect
bioavailability
pharmacokinetic
STI571
modified release formulation of STI571

CML
Chronic Myeloid Leukemia
Philadelphia Chromosome
imatinib

Study placed in the following topic categories:

Imatinib
Philadelphia Chromosome
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Healthy
Chronic Myelogenous Leukemia
Leukemia, Myeloid
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Imatinib
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009