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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00422825
First received: January 15, 2007
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: imatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib

Secondary Outcome Measures:
  • To compare safety and tolerability of 800 mg modified release formulation with or without food.
  • To compare the relative bioavailability of a single dose 800 mg modified release formulation (with a low fat breakfast) with the marketed 400 mg immediate release tablet administered (with a low fat breakfast) twice daily

Estimated Enrollment: 16
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  • Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422825

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422825     History of Changes
Other Study ID Numbers: CSTI571O2102
Study First Received: January 15, 2007
Last Updated: July 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Food effect
bioavailability
pharmacokinetic
imatinib
STI571
modified release formulation of STI571
CML
Chronic Myeloid Leukemia
Philadelphia Chromosome

Additional relevant MeSH terms:
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014