OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS

Study Overview
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Brief Summary
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The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.

Official Title
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A PHASE 1, OPEN LABEL, TWO-PERIOD, RANDOMIZED CROSSOVER STUDY TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT FORMULATIONS OF PF-05221304 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-05221304 Formulation A
* Drug: PF-05221304 Formulation B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages of 18 and 55 years old inclusive Body Mass Index (BMI) of >= 17.5 and <= 30.4 kg/m2 Total body weight > 50 kg (110lb) Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings

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: PF-05221304 Formulation A<br> | Drug: PF-05221304 Formulation A<br>* 50mg<br>|
| Experimental: PF-05221304 Formulation B<br> | Drug: PF-05221304 Formulation B<br>* 50mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma PF-05221304 AUClast | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Thirteen timepoints between 0-72 Hours | 
| Plasma PF-05221304 Cmax | Maximum Observed Plasma Concentration (Cmax) | Thirteen timepoints between 0-72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Experiencing an Adverse Event | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment | Up to 10 weeks from screening | 
| Number of Participants With Clinical Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]). | Up to 10 weeks from screening | 
| Number of Participants With Categorical Vital Signs Data | Number of participants with maximum increase from Baseline in sitting Systolic Blood Pressure and Diastolic Blood Pressure of greater than or equal to 30 mmHg | Up to 10 weeks from screening | 
| Number of Participants With Abnormal Electrocardiogram (ECG) | Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec. | Up to 10 weeks from screening |