A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Official Title
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A Phase 1, Randomized, Open-Label, Single Dose, 2-Cohort Crossover Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered PH-797804 In Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* 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 21 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 21 drinks/week for males.

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: PH-797804 1 mg Fasted<br>Subjects will receive a single 1 mg dose in the fasted state | Drug: PH-797804<br>* Tablet, 1 mg, single dose<br>|
| Experimental: PH-797804 1 mg Fed<br>Subjects will receive a single 1 mg dose following a high-fat meal | Drug: PH-797804<br>* Tablet, 1 mg, single dose<br>|
| Experimental: PH-797804 10 mg Fasted<br>Subjects will receive a single 10 mg dose in the fasted state | Drug: PH-797804<br>* Tablet, 10 mg, single dose<br>|
| Experimental: PH-797804 10 mg Fed<br>Subjects will receive a single 10 mg dose following a high-fat meal | Drug: PH-797804<br>* Tablet, 10 mg, single dose<br>|
| Experimental: PH-797804 24 mg Fed<br>Subjects will receive a single 24 mg dose following a high-fat meal | Drug: PH-797804<br>* Tablet, 24 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: peak plasma concentration |  | 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose | 
| Pharmacokinetics: time to peak plasma concentration |  | 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose | 
| Pharmacokinetics: area under the plasma concentration-time curve |  | 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose | 
| Pharmacokinetics: terminal plasma half-life |  | 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose |