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PF-03463275

Phase 2

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Apr 20, 2011

PF-03463275 development status

Highest phase Phase 2 (NCT00977522)
Phase scored for PFEPhase 1
Registered trials 2 across 1 sponsor since Sep 2009

PF-03463275 target and mechanism

Molecular targetSLC6A9
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

PF-03463275 clinical trials

PF-03463275 · 1 trial · 1 indication

Phase 1 1
NCT01159626Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western SubjectsHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events monitoring
Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B
Vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, suicidality assessment
Screening and Day 0 to Day 4 in each period of Cohort A, Screening and Day 0 to Day 10 in Cohort B
Serum (after single dose): Cmax, AUClast, AUCtau (Calculated only in Cohort B) and as data permit Tmax, AUCinf, t1/2
Day 1 to Day 4 in each period of Cohort A, Day 1 in Cohort B
Serum (after multiple dose): Ctrough, Cmax*, AUCtau* and as data permit Tmax*, t1/2* and Rac* (accumulation ratio) * Calculated only after the last administration.
Day 2 to Day 10 in Cohort B
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single doseEXPERIMENTAL -
Multiple doseEXPERIMENTAL -

Interventions

NameTypeDescription
PF-03463275DRUGOral single 20 mg dose as two 10mg controlled release tablets
PlaceboDRUGOral single dose as matching placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs). * Japanese subjects must have four Japanese grandparents who were born in Japan. Exclusion Criteria: * Subjects that are genot...

Countries:United States
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Frequently asked questions about PF-03463275

What is PF-03463275?

PF-03463275 is an investigational small molecule drug developed by Pfizer, Inc. (NYSE: PFE). It is a selective inhibitor of the glycine transporter 1 (GlyT1) protein, encoded by the SLC6A9 gene. The drug has been studied in a Phase 1 clinical trial in healthy male volunteers.

What does PF-03463275 target?

PF-03463275 targets SLC6A9, which encodes the glycine transporter 1 (GlyT1) protein. It acts as an inhibitor of this transporter. By inhibiting GlyT1, the drug is designed to modulate glycine levels in the brain, a mechanism being explored for potential central nervous system applications.

Who is developing PF-03463275?

PF-03463275 is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the research and clinical development of this investigational compound.

What phase is PF-03463275 in?

PF-03463275 is in Phase 1 clinical development. It has not been approved by the FDA or any regulatory agency. The only reported trial was a Phase 1 study that has been completed, and no active trials are currently listed.

What clinical trials is PF-03463275 in?

PF-03463275 has been evaluated in one completed Phase 1 clinical trial, NCT01159626, titled "Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects." The trial enrolled 40 healthy male volunteers in the United States and was randomized, double-blind, and controlled.