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

Study Overview
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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).

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PF-04531083 or Placebo
* Drug: PF-04531083 or Placebo
* Drug: PF-04531083 or Placebo
* Drug: PF-04531083 or Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index |  | 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) |  | days 1-15 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics safety tolerability multiple dosing