NCT00422825

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

January 15, 2007

Last Update Submit

April 4, 2016

Conditions

Healthy

Keywords

Food effectbioavailabilitypharmacokineticimatinibSTI571modified release formulation of STI571CMLChronic Myeloid LeukemiaPhiladelphia Chromosome

Outcome Measures

Primary Outcomes (1)

  • Assess the effect of food on bioavailability and pharmacokinetics of modified and immediate release formulations of imatinib

Secondary Outcomes (2)

  • 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

Study Arms (2)

Imatinib 800mg

EXPERIMENTAL
Drug: imatinib

Imatinib 400mg

ACTIVE COMPARATOR
Drug: imatinib

Interventions

imatinibDRUG
Imatinib 400mgImatinib 800mg

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subjects (postmenopausal women)
  • Able to communicate well with the investigator and comply with the requirements of the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositivePhiladelphia Chromosome

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTranslocation, GeneticChromosome Aberrations

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 17, 2007

Study Start

June 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

April 5, 2016

Record last verified: 2016-04