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PF-03463275

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 20, 2011

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

Clinical trial landscape

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 used for?

PF-03463275 is an investigational small molecule being studied for use in healthy volunteers. It is not approved for any disease or condition and is currently in clinical development to evaluate its pharmacokinetics, safety, and tolerability.

Who makes PF-03463275?

PF-03463275 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to assess the drug's safety and tolerability in healthy subjects.

What phase is PF-03463275 in?

PF-03463275 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.

What clinical trials is PF-03463275 in?

PF-03463275 has one completed Phase 1 trial, NCT01159626, which studied its pharmacokinetics, safety, and tolerability in healthy male Japanese and Western subjects. The trial enrolled 40 participants and was conducted in the United States.

Is PF-03463275 the same as any other drug?

No alternative names for PF-03463275 have been disclosed. It is identified solely by its code name PF-03463275 in clinical trial records.