The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
50mg
50mg
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Plasma PF-05221304 AUClast
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Thirteen timepoints between 0-72 Hours
Plasma PF-05221304 Cmax
Maximum Observed Plasma Concentration (Cmax)
Time frame: Thirteen timepoints between 0-72 Hours
Number of Subjects Experiencing an Adverse Event
Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment
Time frame: 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 \[urine mucus and leucocytes\]).
Time frame: 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
Time frame: Up to 10 weeks from screening
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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.
Time frame: Up to 10 weeks from screening