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PF-05212365

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 28, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

PF-05212365 · 1 trial · 1 indication

Phase 1 1
NCT01253655To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy VolunteersHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Healthy
NCT012536556
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Study Endpoints

Primary Endpoints

Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects
up to 4 days

Secondary Endpoints

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
continuous, up to 4 days
Change from baseline in orthostatic blood pressure
Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose
Change from baseline in supine blood pressure
Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-05212365EXPERIMENTAL -

Interventions

NameTypeDescription
PF-05212365DRUGSingle dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiat...

Countries:United States
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Frequently asked questions about PF-05212365

What is PF-05212365?

PF-05212365 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate the relationship between plasma drug levels and receptor binding in the brain using positron emission tomography (PET).

What is PF-05212365 used for?

PF-05212365 is being studied for use in healthy volunteers. The purpose of the clinical trial is to evaluate the relationship between plasma drug levels and receptor binding in the brain using positron emission tomography (PET). It is not being developed for a specific disease indication at this stage.

Who makes PF-05212365?

PF-05212365 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is PF-05212365 in?

PF-05212365 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is PF-05212365 in?

PF-05212365 has been studied in one completed Phase 1 clinical trial, identified as NCT01253655. This trial enrolled 6 healthy volunteers in the United States and evaluated the relationship between plasma drug levels and receptor binding in the brain using positron emission tomography (PET).