A Study Of Three PF-05190457 Formulations In Healthy Volunteers

January 27, 2012 updated by: Pfizer

A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers

The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100 mg PF-05190457
Three fasted treatments and fed with the short-duration osmotic capsule
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
Experimental: 100 mg PF - 05190457
Three fasted treatments and fed with the long-duration osmotic capsule
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit.
Time Frame: 0 - 48 hours post dose
0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit.
Time Frame: 0 - 48 hours post dose
0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit.
Time Frame: 0 - 48 hours post dose
0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit.
Time Frame: 0 - 48 hours post dose
0 - 48 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit.
Time Frame: 0 - 48 hours post dose
0 - 48 hours post dose
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit.
Time Frame: 0 - 48 hours post dose
0 - 48 hours post dose
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
Time Frame: 0 - 24 hours post dose
0 - 24 hours post dose

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3301007

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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