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PF-03654764

Phase 2

Allergic Rhinitis | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Aug 17, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

PF-03654764 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT01033396The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic RhinitisAllergic Rhinitis
COMPLETED64 Analytics
PHASE2COMPLETED
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Congestion scores
6 hours
Other allergic rhinitis symptoms
6 hours
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination.
10 days

Secondary Endpoints

Pharmacokinetics
6 hours
Blood pressure/pulse rate
6 hours
Adverse event reporting
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-03654764 + AllegraEXPERIMENTAL -
PF-03654764EXPERIMENTAL -
Allegra-DACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Cohort 1EXPERIMENTALSubjects will be assigned to receive either PF-03654764 or placebo.
Cohort 2EXPERIMENTALSubjects will be assigned to receive either PF-03654764 or placebo.
Cohort 3EXPERIMENTALSubjects will be assigned to receive either PF-03654764 or placebo.

Interventions

NameTypeDescription
PF-03654764DRUGPF-03654764 single dose 5 mg
AllegraDRUGFexofenadine single dose 60 mg
Allegra-DDRUGFexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
PlaceboDRUGPlacebo single dose
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects 18-60 years allergic to ragweed pollen. * Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit. Exclusion Criteria: * Subjects with significant diseases other than allergic rhinitis that may interfe...

Countries:CanadaSingapore
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Competitive Landscape -Allergic Rhinitis 4 trials

Frequently asked questions about PF-03654764

What is PF-03654764 used for?

PF-03654764 is an investigational small molecule being developed by Pfizer for respiratory conditions, specifically studied in healthy volunteers and in patients with allergic rhinitis. It has been evaluated in clinical trials for safety, toleration, and its effect on symptoms of allergic rhinitis.

Who makes PF-03654764?

PF-03654764 is developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with allergic rhinitis.

What phase is PF-03654764 in?

PF-03654764 has completed a Phase 2 clinical trial for allergic rhinitis and a Phase 1 trial in healthy volunteers. It is an investigational drug, not approved by regulatory authorities, and no active trials are currently listed.

What clinical trials is PF-03654764 in?

PF-03654764 has been studied in two completed trials: NCT00989391, a Phase 1 study in healthy people in Singapore to investigate safety, toleration, and blood concentrations, and NCT01033396, a Phase 2 study in Canada evaluating its effect on allergic rhinitis symptoms.

Is PF-03654764 the same as Allegra?

No, PF-03654764 is not the same as Allegra. In a clinical trial, PF-03654764 was studied alone and in combination with Allegra (fexofenadine) to assess its effect on allergic rhinitis symptoms, indicating they are distinct drugs.