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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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: 150 mg Suspension
Drug: 30 mg Suspension
Drug: 400 mg Suspension
Drug: 5 mg Suspension
Drug: 750 mg Suspension
Drug: 150 mg Tablet
Drug: 30 mg Tablet
Drug: 400 mg Tablet
Drug: 5 mg Tablet
Drug: 750 mg Tablet
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: An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics: Cmax, AUCinf [ Time Frame: June - July 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax, Tlag, AUClast, AUCt, t½, Frel. [ Time Frame: June-July 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suspension
PF-02413873 suspension
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
Experimental: Tablet
PF-02413873 Phase 2 Tablets
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00857571

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00857571     History of Changes
Other Study ID Numbers: B0461003
Study First Received: March 5, 2009
Last Updated: October 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Dose Response Bioavailability Study

ClinicalTrials.gov processed this record on November 20, 2014