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.

December 5, 2018 updated by: Pfizer

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: June - July 2009
June - July 2009

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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