Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

April 15, 2010 updated by: Pfizer

A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

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

      • Bruxelles, Belgium, 1070
        • 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and/or female subjects btween the ages of 18-55 years
  • Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
  • Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  • Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
Experimental: Cohort 2
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
Experimental: Cohort 3
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
Experimental: Cohort 4
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
Time Frame: days 1-15
days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
Time Frame: days 1-15
days 1-15

Secondary Outcome Measures

Outcome Measure
Time Frame
pharmacokinetics of alternative formulations
Time Frame: days 1-15
days 1-15

Collaborators and Investigators

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

Sponsor

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.

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

November 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 11, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

April 16, 2010

Last Update Submitted That Met QC Criteria

April 15, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • B1351002

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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