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PF-05212377

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 16, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

PF-05212377 · 3 trials · 1 indication

Phase 1 3
NCT02005991A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377Healthy
COMPLETED4 Analytics
NCT01258751This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy VolunteersHealthy
COMPLETED12 Analytics
NCT01159496Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)Healthy
COMPLETED60 Analytics
PHASE1COMPLETED
A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377
Healthy
NCT020059914
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PHASE1COMPLETED
This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Healthy
NCT0125875112
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PHASE1COMPLETED
Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)
Healthy
NCT0115949660
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Study Endpoints

Primary Endpoints

5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
Days 1 and 2
Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy
Days 1 and 2
To assess the central 5-HT6 receptor occupancy (RO) in the striatum in relation to systemic exposure of PF-05212377 after single oral administration in healthy adult subjects.
up to 8 days
Adverse events (spontaneous and solicited).
0-24days
Change from baseline in vital signs.
0-24 days
Change from baseline in triplicate ECGs.
0-24 days
Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive.
0-24 days
Physical examinations and neurological examinations
0-24 days

Secondary Endpoints

5-HT2a receptor occupancy of PF-05212377 in other cortical regions
Day 1 and 2
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
continuous, up to 8 days
Maximum concentration (Cmax) for PF-05212377 in plasma
up to 8 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-05212377 70 mgEXPERIMENTAL -
PF-05212377 20 mgEXPERIMENTAL -
PF-05212377 10 mgEXPERIMENTAL -
PF-05212377EXPERIMENTAL -
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-05212377DRUGSingle, oral dose administration of 70 mg PF-0521377 using a capsule formulation.
PF-05212377 (SAM-760)DRUGOral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg
PlaceboDRUGOral capsule, once daily for 14 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.5. * Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures. Exc...

Countries:United StatesFrance
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Frequently asked questions about PF-05212377

What is PF-05212377 used for?

PF-05212377 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in Phase 1 clinical trials to assess its safety, tolerability, and pharmacokinetics. The drug is also being studied to examine its distribution in the brain using positron emission tomography (PET) imaging.

Who makes PF-05212377?

PF-05212377 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored three Phase 1 clinical trials of this investigational small molecule, all of which have been completed.

What phase is PF-05212377 in?

PF-05212377 is in Phase 1 clinical development. All three of its clinical trials have been completed, with a total enrollment of 76 participants. The drug is investigational and has not been approved for any use.

What clinical trials is PF-05212377 in?

PF-05212377 has been studied in three completed Phase 1 trials: NCT01159496, a multiple ascending dose study in healthy volunteers in France; NCT01258751, a PET study in the United States; and NCT02005991, a brain distribution study in the United States.

Is PF-05212377 the same as SAM-760?

Yes, PF-05212377 is also known as SAM-760. The multiple ascending dose study NCT01159496 refers to the drug as PF-05212377 (SAM-760), confirming that these names refer to the same investigational compound.