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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05221304 Formulation B; Drug: PF-05221304 Formulation A

• Registration Number: NCT03871439
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-03-13
• Primary Completion: 2019-05-08
• Study Completion: 2019-05-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

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Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-05221304 Formulation B	PF-05221304 Formulation B	-
PF-05221304 Formulation A	PF-05221304 Formulation A	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States