Healthy
Conditions
Brief summary
The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.
Interventions
DRUGPF-05221304 Formulation A
50mg
DRUGPF-05221304 Formulation B
50mg
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PF-05221304 AUClast | Thirteen timepoints between 0-72 Hours | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
| Plasma PF-05221304 Cmax | Thirteen timepoints between 0-72 Hours | Maximum Observed Plasma Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing an Adverse Event | Up to 10 weeks from screening | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment |
| Number of Participants With Clinical Laboratory Abnormalities | Up to 10 weeks from screening | 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 \[urine mucus and leucocytes\]). |
| Number of Participants With Categorical Vital Signs Data | Up to 10 weeks from screening | 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 |
| Number of Participants With Abnormal Electrocardiogram (ECG) | Up to 10 weeks from screening | 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. |
Countries
United States
Outcome results
None listed