Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00420043
First received: January 8, 2007
Last updated: November 20, 2009
Last verified: November 2009

January 8, 2007
November 20, 2009
September 2006
Not Provided
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).
Same as current
Complete list of historical versions of study NCT00420043 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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Effect of Food on Bioavailability of Modified Release Formulations of Imatinib
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: imatinib
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
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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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00420043
CSTI571O 2103
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Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP