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

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Cmax, AUCinf	June - July 2009

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax, Tlag, AUClast, AUCt, t½, Frel.	June-July 2009

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Dose Response Bioavailability Study
• Other Study ID Numbers: B0461003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No