A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects

March 8, 2012 updated by: Pfizer

A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04937319 In Overweight And Obese Otherwise Healthy Subjects

This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319

Study Overview

Status

Completed

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
  • Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
  • Body Mass Index (BMI) of 23 to 33 kg/m2 and a total body weight >=50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated seasonal allergies).
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pf-04937319: Maximum plasma concentration (Cmax)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
Pf-04937319: Time for Cmax (Tmax)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
Pf-04937319: terminal half-life (T1/2)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
PF-06455349: Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time Frame: 0 - 96 hours post dose
0 - 96 hours post dose
PF-06455349: Plasma Decay Half-Life (t1/2)
Time Frame: 0 - 96 hours post dose
0 - 96 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

January 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B1621005

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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