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

Criteria

Inclusion Criteria:

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

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 May 23, 2013