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PF-05221304 Formulation A

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: May 20, 2020

PF-05221304 Formulation A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

PF-05221304 Formulation A clinical trials

PF-05221304 Formulation A · 1 trial · 1 indication

Phase 1 1
NCT03871439OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTSHealthy
COMPLETED10 Analytics
PHASE1COMPLETED
OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Number of Subjects Experiencing an Adverse Event
Up to 10 weeks from screening
Number of Participants With Clinical Laboratory Abnormalities
Up to 10 weeks from screening
Number of Participants With Categorical Vital Signs Data
Up to 10 weeks from screening
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-05221304 Formulation AEXPERIMENTAL -
PF-05221304 Formulation BEXPERIMENTAL -

Interventions

NameTypeDescription
PF-05221304 Formulation ADRUG50mg
PF-05221304 Formulation BDRUG50mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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,...

Countries:United States
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Frequently asked questions about PF-05221304 Formulation A

What is PF-05221304 Formulation A?

PF-05221304 Formulation A is an investigational small molecule developed by Pfizer, Inc. It is a specific formulation of PF-05221304 that was studied in a Phase 1 bioavailability trial comparing it against another formulation of the same compound in healthy adult volunteers.

Who is developing PF-05221304 Formulation A?

Pfizer, Inc. is developing PF-05221304 Formulation A. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 1 bioavailability study of this formulation.

What phase is PF-05221304 Formulation A in?

PF-05221304 Formulation A is in Phase 1 development. It is investigational and has not been approved by the FDA. The single Phase 1 trial of this formulation has been completed, and no trials of it are currently active.

What clinical trial is PF-05221304 Formulation A in?

PF-05221304 Formulation A was studied in NCT03871439, an open label, two period Phase 1 study comparing the bioavailability of two different formulations of PF-05221304 in healthy adults. The trial enrolled 10 participants in the United States and has been completed.

What was the design of the PF-05221304 Formulation A trial?

NCT03871439 was an open label, two period bioavailability study of PF-05221304 Formulation A in healthy adults aged 18 years and older. It was a controlled, randomized trial with 10 participants, conducted in the United States, and it has been completed.