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

Healthy Clinical Trial

Official title:

A PHASE 1, OPEN LABEL, TWO-PERIOD, RANDOMIZED CROSSOVER STUDY TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT FORMULATIONS OF PF-05221304 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871439
• Other study ID #: C1171007
• Status: Completed
• Phase: Phase 1
• Start date: March 13, 2019
• Est. completion date: May 8, 2019

Study information

• Verified date: May 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 8, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-05221304 Formulation A
50mg
• PF-05221304 Formulation B
50mg

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma PF-05221304 AUClast	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Thirteen timepoints between 0-72 Hours
Primary	Plasma PF-05221304 Cmax	Maximum Observed Plasma Concentration (Cmax)	Thirteen timepoints between 0-72 Hours
Secondary	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
Secondary	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]).	Up to 10 weeks from screening
Secondary	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
Secondary	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

External Links

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