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The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05221304 Formulation A | Experimental |
| |
| PF-05221304 Formulation B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05221304 Formulation A | Drug | 50mg |
| |
| PF-05221304 Formulation B |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Drug |
50mg |
|
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]).](streamdown:incomplete-link)
| 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 |