A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

Study Overview
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Brief Summary
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The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Official Title
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An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.

Conditions
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Healthy

Intervention / Treatment
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* Drug: 150 mg Suspension
* Drug: 30 mg Suspension
* Drug: 400 mg Suspension
* Drug: 5 mg Suspension
* Drug: 750 mg Suspension
* Drug: 150 mg Tablet
* Drug: 30 mg Tablet
* Drug: 400 mg Tablet
* Drug: 5 mg Tablet
* Drug: 750 mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female volunteers. Female volunteers have to be of non-childbearing potential Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen.

Ages Eligible for Study
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Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspension<br>PF-02413873 suspension | Drug: 150 mg Suspension<br>* Single oral dose of 150 mg of PF-02413873 suspension<br>Drug: 30 mg Suspension<br>* Single oral dose of 30 mg of PF-02413873 suspension<br>Drug: 400 mg Suspension<br>* Single oral dose of 400 mg of PF-02413873 suspension<br>Drug: 5 mg Suspension<br>* Single oral dose of 5 mg of PF-02413873 suspension<br>Drug: 750 mg Suspension<br>* Single oral dose of 750 mg of PF-02413873 suspension<br>|
| Experimental: Tablet<br>PF-02413873 Phase 2 Tablets | Drug: 150 mg Tablet<br>* Single oral dose of 150 mg of PF-02413873 tablets<br>Drug: 30 mg Tablet<br>* Single oral dose of 30 mg of PF-02413873 tablets<br>Drug: 400 mg Tablet<br>* Single oral dose of 400 mg of PF-02413873 tablets<br>Drug: 5 mg Tablet<br>* Single oral dose of 5 mg of PF-02413873 tablets<br>Drug: 750 mg Tablet<br>* Single oral dose of 750 mg of PF-02413873 tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Cmax, AUCinf |  | June - July 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, Tlag, AUClast, AUCt, t½, Frel. |  | June-July 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dose Response Bioavailability Study