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A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

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ClinicalTrials.gov Identifier: NCT00857571
Recruitment Status : Terminated
First Posted : March 6, 2009
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 5, 2009
First Posted Date  ICMJE March 6, 2009
Last Update Posted Date December 7, 2018
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
Pharmacokinetics: Cmax, AUCinf [ Time Frame: June - July 2009 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00857571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2009)
Tmax, Tlag, AUClast, AUCt, t½, Frel. [ Time Frame: June-July 2009 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.
Official Title  ICMJE An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.
Brief Summary The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 150 mg Suspension
    Single oral dose of 150 mg of PF-02413873 suspension
  • Drug: 30 mg Suspension
    Single oral dose of 30 mg of PF-02413873 suspension
  • Drug: 400 mg Suspension
    Single oral dose of 400 mg of PF-02413873 suspension
  • Drug: 5 mg Suspension
    Single oral dose of 5 mg of PF-02413873 suspension
  • Drug: 750 mg Suspension
    Single oral dose of 750 mg of PF-02413873 suspension
  • Drug: 150 mg Tablet
    Single oral dose of 150 mg of PF-02413873 tablets
  • Drug: 30 mg Tablet
    Single oral dose of 30 mg of PF-02413873 tablets
  • Drug: 400 mg Tablet
    Single oral dose of 400 mg of PF-02413873 tablets
  • Drug: 5 mg Tablet
    Single oral dose of 5 mg of PF-02413873 tablets
  • Drug: 750 mg Tablet
    Single oral dose of 750 mg of PF-02413873 tablets
Study Arms  ICMJE
  • Experimental: Suspension
    PF-02413873 suspension
    Interventions:
    • Drug: 150 mg Suspension
    • Drug: 30 mg Suspension
    • Drug: 400 mg Suspension
    • Drug: 5 mg Suspension
    • Drug: 750 mg Suspension
  • Experimental: Tablet
    PF-02413873 Phase 2 Tablets
    Interventions:
    • Drug: 150 mg Tablet
    • Drug: 30 mg Tablet
    • Drug: 400 mg Tablet
    • Drug: 5 mg Tablet
    • Drug: 750 mg Tablet
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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2009)
30
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female volunteers.
  • Female volunteers have to be of non-childbearing potential

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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00857571
Other Study ID Numbers  ICMJE B0461003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP