A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State

Study Overview
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Brief Summary
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The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.

Official Title
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A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule

Conditions
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Pain

Intervention / Treatment
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* Drug: PF-05089771
* Drug: PF-05089771


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years 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. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds >120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-05089771 Oral Dispersion fasted<br>Oral dispersion TS formulation- fasted | Drug: PF-05089771<br>* Oral dispersion TS formulation- fasted<br>|
| Experimental: PF-05089771 TS formulation fasted<br>Capsules TS formulation- fasted | Drug: PF-05089771<br>* Capsules TS formulation- fasted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) |  | days 1-2 | 
| AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) |  | days 1-2 | 
| AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) |  | days 1-2 | 
| Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) |  | days 1-2 | 
| t½ = Elimination half life of PF-05089771 (hr) |  | days 1-2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. |  | days 1-2 |