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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.

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00857571
First received: March 5, 2009
Last updated: October 22, 2010
Last verified: October 2010

March 5, 2009
October 22, 2010
April 2009
May 2009   (final data collection date for primary outcome measure)
Pharmacokinetics: Cmax, AUCinf [ Time Frame: June - July 2009 ] [ Designated as safety issue: No ]
Pharmacokinetics: Cmax, AUCinf [ Time Frame: June - July 2009 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00857571 on ClinicalTrials.gov Archive Site
Tmax, Tlag, AUClast, AUCt, t½, Frel. [ Time Frame: June-July 2009 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.

The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00857571
B0461003
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

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