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PF-03049423

Phase 2

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Aug 9, 2011

PF-03049423 development status

Highest phase Phase 2 (NCT01208233)
Phase scored for PFEPhase 1
Registered trials 2 across 1 sponsor since Jul 2010

PF-03049423 target and mechanism

Molecular targetPDE5A
Target classInhibitor
ModalitySmall molecule

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

PF-03049423 clinical trials

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
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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?

PF-03049423 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It is a PDE5A inhibitor that has been studied in Phase 1 clinical development. The specific therapeutic indication for PF-03049423 has not been disclosed, and the compound has been evaluated in healthy adult and older adult volunteers rather than in a patient population.

What does PF-03049423 target?

PF-03049423 targets PDE5A, also known as phosphodiesterase type 5A. It is classified as a PDE5A inhibitor, meaning it acts by inhibiting the enzymatic activity of this phosphodiesterase. This target class places PF-03049423 among small molecule PDE5A inhibitors, a mechanism that modulates cyclic nucleotide signaling through PDE5A inhibition.

Who makes PF-03049423?

PF-03049423 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program for this investigational PDE5A inhibitor small molecule. No other developer or partner is associated with PF-03049423 based on its development record.

What phase is PF-03049423 in?

PF-03049423 is in Phase 1 clinical development. It is an investigational agent and is not approved for any indication. The Phase 1 program has been completed, with one completed trial and no active trials currently listed for PF-03049423.

What clinical trials is PF-03049423 in?

PF-03049423 has been studied in one Phase 1 trial, NCT01161069, titled a study to evaluate the safety and tolerability of different doses of PF-03049423 in healthy adult volunteers and healthy older volunteers. That trial was completed, enrolled 48 participants, was randomized, double blind, and placebo controlled, and was conducted in Belgium.

What was the design of the PF-03049423 Phase 1 trial?

The PF-03049423 Phase 1 trial NCT01161069 was a randomized, double blind, placebo controlled study of different doses in healthy adult and healthy older volunteers. It enrolled 48 participants of all sexes, aged 18 years and older, and was conducted in Belgium. The trial has been completed.