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A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

Last updated on November 11, 2019

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Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects of non-childbearing potential between the ages of
18 and 55 years, inclusive. Healthy is defined as no clinically relevant
abnormalities identified by a detailed medical history, full physical examination,
including blood pressure and pulse rate measurement, 12 lead ECG or clinical
laboratory tests.

- Female subjects of non child bearing potential must have a Body Mass Index (BMI) of
17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Pregnant or nursing females; females of childbearing potential.

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of study medication.
Limited use of non prescription medications that are not believed to affect subject
safety or the overall results of the study may be permitted on a case-by-case basis
following approval by the sponsor.

NCT02006277
Pfizer
Completed
A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

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Descriptive Information
Brief Title  ICMJE A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation
Official Title  ICMJE A Phase 1, Open-label, Crossover Taste And Pharmacokinetic Study In Healthy Adult Volunteers To Evaluate The Palatability And Estimate The Bioavailability Of Three Prototype Formulations Of Crizotinib
Brief SummaryThis study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Crizotinib prototype microsphere 0.529 mg/mg
    Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
  • Drug: crizotinib prototype microsphere 0.470 mg/mg
    Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
  • Drug: crizotinib prototype microsphere 0.420 mg/mg
    Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
  • Drug: crizotinib oral solution
    Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
  • Drug: crizotinib prototype microsphere 0.529 mg/mg
    Subjects will receive a single 250-mg oral dose of crizotinib.
  • Drug: crizotinib prototype microsphere 0.470 mg/mg
    Subjects will receive a single 250-mg oral dose of crizotinib.
  • Drug: crizotinib prototype microsphere 0.420 mg/mg
    Subjects will receive a single 250-mg oral dose of crizotinib.
  • Drug: crizotinib capsule
    Subjects will receive a single 250-mg oral dose of crizotinib.
  • Drug: crizotinib oral solution
    Subjects will receive a single 250-mg oral dose of crizotinib.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Cohort 1 will be an open label, randomized, 4 period, 4 treatment, 4 sequence, cross over sensory evaluation of three new prototype formulations (75 mg dose of crizotinib as prototypes 0.529 mg/mg, 0.470 mg/mg and 0.420 mg/mg Microspheres) and OS (75 mg dose of crizotinib)via use of a Crizotinib Taste Assessment - Questionnaire for Cohort 1 in healthy adults.
    Interventions:
    • Drug: Crizotinib prototype microsphere 0.529 mg/mg
    • Drug: crizotinib prototype microsphere 0.470 mg/mg
    • Drug: crizotinib prototype microsphere 0.420 mg/mg
    • Drug: crizotinib oral solution
  • Experimental: Cohort 2
    This cohort will be an open label, randomized, 5 period, 5 treatment, 4 sequence, cross over single dose bioavailability study employing administration of four crizotinib formulations Treatments E, F, G and H (Crizotinib 250 mg dose Formulated Capsule and 250 mg dose crizotinib as prototypes 0.529 mg/mg, 0.470 mg/mg and 0.420 mg/mg Microspheres, respectively) in the fasted state to healthy adult subjects (Periods 1-4). In addition, Treatment I (250 mg dose of crizotinib OS) will be administered at Period 5, for a taste evaluation only (no pharmacokinetic (PK) sample collection after the dose), in the period immediately following the completion of Period 4 of Cohort 2. A Crizotinib Taste Assessment - Questionnaire for Cohort 2 will be filled by all subjects.
    Interventions:
    • Drug: crizotinib prototype microsphere 0.529 mg/mg
    • Drug: crizotinib prototype microsphere 0.470 mg/mg
    • Drug: crizotinib prototype microsphere 0.420 mg/mg
    • Drug: crizotinib capsule
    • Drug: crizotinib oral solution
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2013)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion DateMarch 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
  • Female subjects of non child bearing potential must have a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Pregnant or nursing females; females of childbearing potential.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02006277
Other Study ID Numbers  ICMJE A8081041
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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