A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804

Official Title
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A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)

Conditions
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Healthy

Intervention / Treatment
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* Drug: PH-797804
* Drug: PH-797804
* Drug: PH-797804
* Drug: PH-797804
* Drug: PH-797804
* Drug: PH-797804


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; 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 males.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PH-797804 PARTICLE SIZE 9-11UM<br> | Drug: PH-797804<br>* Tablet, 6 mg, single dose<br>|
| Experimental: PH-797804 PARTICLE SIZE 9-11UM WITH SLS<br> | Drug: PH-797804<br>* Tablet, 6 mg, single dose<br>|
| Experimental: PH-797804 PARTICLE SIZE <= 20UM<br> | Drug: PH-797804<br>* Tablet, 6 mg, single dose<br>|
| Experimental: PH-797804 PARTICLE SIZE <= 20UM WITH SLS<br> | Drug: PH-797804<br>* Tablet, 6 mg, single dose<br>|
| Experimental: PH-797804 PARTICLE SIZE <= 5UM<br> | Drug: PH-797804<br>* Tablet, 6 mg, single dose<br>|
| Experimental: PH-797804 PARTICLE SIZE <= 5UM WITH SLS<br> | Drug: PH-797804<br>* Tablet, 6 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Time 72 hours (AUC72) | Area under the plasma concentration time-curve from zero to 72 hours (AUC72) | 0,2,3,4,5,6,8,12,24,48,72 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0,2,3,4,5,6,8,12,24,48,72 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0,2,3,4,5,6,8,12,24,48,72 hours post-dose |