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PF-05212365

Phase 2

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Apr 28, 2011

PF-05212365 development status

Highest phase Phase 2 (NCT00481520)
Phase scored for PFEPhase 1
Registered trials 10 across 2 sponsors since May 2007

PF-05212365 target and mechanism

ModalitySmall molecule

Also known as SAM-531

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

PF-05212365 clinical trials

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
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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 developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial involving healthy adult volunteers in the United States. The specific disease indications for which it was being developed have not been publicly disclosed.

Who is developing PF-05212365?

PF-05212365 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound conducted in the United States.

What phase is PF-05212365 in?

PF-05212365 is in Phase 1 clinical development. It is an investigational small molecule that has not been approved by the FDA. 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 evaluated in one completed Phase 1 trial, NCT01253655, titled "To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers." The study enrolled 6 healthy adult volunteers in the United States and was uncontrolled.

What was the design of the PF-05212365 Phase 1 trial?

The Phase 1 trial NCT01253655 was an uncontrolled study that enrolled 6 healthy volunteers aged 18 years and older in the United States. It used positron emission tomography (PET) to evaluate the relationship between plasma drug levels of PF-05212365 and receptor binding in the brain. The trial is completed.