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Relative Drug Exposures Of Two Formulations of PF-02341066

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ClinicalTrials.gov Identifier: NCT00939731
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : October 18, 2011
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-02341066 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I Relative Bioavailability Study To Compare The Powder-In-Capsule And Immediate Release Tablet Of PF-02341066 In Healthy Volunteers
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: PIC Drug: PF-02341066
A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Powder-in-Capsule and 2 x 100-mg Powder-in-Capsules
Experimental: IRT Drug: PF-02341066
A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Immediate Release Tablet and 2 x 100-mg Immediate Release Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]
    Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]

Secondary Outcome Measures :
  1. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]
  2. Plasma Decay Half Life (t1/2) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  3. Apparent Oral Clearance (CL/F) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

  4. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female of non-childbearing potential subjects 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 electrocardiogram(ECG) and clinical laboratory tests).

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).
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone(FSH) test results at Screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939731


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00939731    
Other Study ID Numbers: A8081008
First Posted: July 15, 2009    Key Record Dates
Results First Posted: October 18, 2011
Last Update Posted: October 24, 2011
Last Verified: October 2011
Keywords provided by Pfizer:
bioavailability, capsule, tablet, healthy volunteer
Additional relevant MeSH terms:
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Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action