Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: imatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00420043

CSTI571O2103

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.