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

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Study arms

• Experimental
  PF-05221304 Formulation A

  Drug: PF-05221304 Formulation A

• Experimental
  PF-05221304 Formulation B

  Drug: PF-05221304 Formulation B

Interventions

• DrugPF-05221304 Formulation A

  50mg

• DrugPF-05221304 Formulation B

  50mg

Primary outcomes

1. Plasma PF-05221304 AUClast

   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

   Time frame: Thirteen timepoints between 0-72 Hours

2. Plasma PF-05221304 Cmax

   Maximum Observed Plasma Concentration (Cmax)

   Time frame: Thirteen timepoints between 0-72 Hours

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

Individual participant data

Plan to share: No — 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.