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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF-04531083 or Placebo

Intervention Type DRUG

Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.

Cohort 2

Group Type EXPERIMENTAL

PF-04531083 or Placebo

Intervention Type DRUG

Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.

Cohort 3

Group Type EXPERIMENTAL

PF-04531083 or Placebo

Intervention Type DRUG

Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.

Cohort 4

Group Type EXPERIMENTAL

PF-04531083 or Placebo

Intervention Type DRUG

A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

Interventions

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PF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.

Intervention Type DRUG

PF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.

Intervention Type DRUG

PF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.

Intervention Type DRUG

PF-04531083 or Placebo

A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes