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

NCT ID: NCT00422825

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2006-09-30

Brief Summary

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

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imatinib 800mg

Group Type: EXPERIMENTAL

imatinib

Intervention Type: DRUG

Imatinib 400mg

Group Type: ACTIVE_COMPARATOR

imatinib

Intervention Type: DRUG

Interventions

imatinib

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

CSTI571O2102

Identifier Type: -

Identifier Source: org_study_id