This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

Study Overview
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Brief Summary
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The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Official Title
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An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment D
* Drug: Treatment E
* Drug: Treatment F
* Drug: Treatment G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. Pregnant or nursing females.

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: Treatment A PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment A<br>* PF-04764793 250/50 using inhaler A<br>|
| Experimental: Treatment B PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment B<br>* PF-04764793 250/50 using inhaler A<br>|
| Experimental: Treatment C PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment C<br>* PF-04764793 250/50 using inhaler A<br>|
| Experimental: Treatment D PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment D<br>* PF-04764793 250/50 using inhaler A<br>|
| Experimental: Treatment E PF-04764793<br>PF-04764793 using inhaler B | Drug: Treatment E<br>* PF-04764793 250/50 using inhaler B<br>|
| Experimental: Treatment F PF-04764793<br>PF-04764793 using inhaler B | Drug: Treatment F<br>* PF-04764793 250/50 using inhaler B<br>|
| Experimental: Treatment G PF-04764793<br>PF-04764793 using inhaler B | Drug: Treatment G<br>* PF-04764793 250/50 using inhaler B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793 |  | 48 hours | 
| Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793. |  | 48 hours | 
| Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793. |  | 48 hours | 
| Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma. |  | 48 hours | 
| Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793. |  | 48 hours |