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PF-03049423

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 9, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

PF-03049423 · 1 trial · 1 indication

Phase 1 1
NCT01161069A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older VolunteersHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events.
Days 1 through 14
PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma.
Day 1
PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr.
Day 14

Secondary Endpoints

Blood pressure
Days 1 to 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
PF-03049423ACTIVE_COMPARATORCohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers
DrugPLACEBO_COMPARATORPlacebo in oral solution, given once daily for 14 days

Interventions

NameTypeDescription
PF-03049423DRUGPF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers
PlaceboDRUGPlacebo in oral solution, given once daily for 14 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy persons, male or female. * For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive. * For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive. * Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (...

Countries:Belgium
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Frequently asked questions about PF-03049423

What is PF-03049423 used for?

PF-03049423 is an investigational small molecule being studied for use in healthy adults and healthy older volunteers. It is currently in Phase 1 clinical development, and its safety and tolerability are being evaluated in this population.

Who makes PF-03049423?

PF-03049423 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange.

What phase is PF-03049423 in?

PF-03049423 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-03049423 in?

PF-03049423 has one completed clinical trial, identified as NCT01161069. This Phase 1 study evaluated the safety and tolerability of different doses of PF-03049423 in healthy adult volunteers and healthy older volunteers in Belgium.

Is PF-03049423 the same as any other drug?

No alternative names for PF-03049423 have been disclosed. It is identified by its compound number, PF-03049423, in clinical trial records.