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CompletedNCT00420043Updated Apr 5, 2016

Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

A Phase 1 interventional study of imatinib in Healthy, sponsored by Novartis. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-05.

Sponsored by Novartis · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • Food effect
  • bioavailability
  • pharmacokinetic
  • STI571
  • modified release formulation of STI571
  • CML
  • Chronic Myeloid Leukemia
  • Philadelphia Chromosome
  • imatinib
03

In context

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    imatinib 800mg

    Drug: imatinib

  • Active comparator
    imatinib 400mg

    Drug: imatinib

Interventions

  • Drugimatinib

    Also known as: STI571

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. To compare safety and tolerability of the 800 mg daily dose modified release formulations with or without food

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00420043
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Jan 9, 2007
Start date
Sep 2006
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Apr 5, 2016

Study contacts

Novartis Pharmaceuticals
study director · Novartis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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