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PF-05221304 Formulation A

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 20, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

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
Healthy
NCT0387143910
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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 used for?

PF-05221304 Formulation A is an investigational small molecule being studied in healthy adults. It is being evaluated in a clinical trial to compare the bioavailability of two different formulations of PF-05221304. The drug is not approved and remains in clinical development.

Who makes PF-05221304 Formulation A?

PF-05221304 Formulation A is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical research on this investigational small molecule in healthy adult volunteers.

What phase is PF-05221304 Formulation A in?

PF-05221304 Formulation A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under study.

What clinical trials is PF-05221304 Formulation A in?

PF-05221304 Formulation A has one completed Phase 1 clinical trial, identified as NCT03871439. This open-label, 2-period study compared the bioavailability of two different formulations of PF-05221304 in healthy adults in the United States. The trial enrolled 10 participants.

Is PF-05221304 Formulation A the same as PF-05221304?

PF-05221304 Formulation A is a specific formulation of the drug PF-05221304. The clinical trial NCT03871439 was designed to compare the bioavailability of two different formulations of PF-05221304, with Formulation A being one of the versions tested in healthy adults.