Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

Study Overview
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Brief Summary
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This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).

Official Title
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A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects 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 measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), 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)

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: Oral disperion fasted<br>A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions. | Drug: PF-05089771<br>* 450mg<br>* Other names: no specified;|
| Experimental: Capsule fasted<br>single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions | Drug: PF-05089771<br>* 450mg<br>* Other names: no specified;|
| Experimental: Capsule fed<br>single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions | Drug: PF-05089771<br>* 450mg<br>* Other names: no specified;|

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 Extrapolated Infinite Time [AUC (0 - 8)] |  | 48 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance |  | 48 hours |