Relative Drug Exposures Of Two Formulations of PF-02341066

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00939731
First received: July 14, 2009
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Healthy
Drug: PF-02341066
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).

  • 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 ] [ Designated as safety issue: No ]
    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-∞).

  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939731

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00939731     History of Changes
Other Study ID Numbers: A8081008
Study First Received: July 14, 2009
Results First Received: September 12, 2011
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
bioavailability, capsule, tablet, healthy volunteer

Additional relevant MeSH terms:
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014