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PF-06263726

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 17, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

PF-06263726 · 1 trial · 1 indication

Phase 1 1
NCT01981681A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy SubjectsHealthy
COMPLETED47 Analytics
PHASE1COMPLETED
A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Draize toxicity assessment score.
Day 8, Day 28

Changes from baseline on Draize toxicity assessment score.

Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.
Day 23, Day 28
Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
Day 23, Day 28

Quantitative changes in ECG intervals.

Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.
Day 23, Day 28
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
Day 23, Day 28

Secondary Endpoints

Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
Day 1, Day 14
Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Day 1, Day 14
Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
Day 1, Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1 Experimental ArmEXPERIMENTAL -
Cohort 2 Experimental ArmEXPERIMENTAL -
Cohort 3 Experimental ArmEXPERIMENTAL -
Cohort 3 Placebo ArmPLACEBO_COMPARATOR -
Cohort 4 Experimental ArmEXPERIMENTAL -
Cohort 4 Placebo ArmPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-06263726DRUGSubjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
PlaceboDRUGSubjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse ...

Countries:Belgium
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Frequently asked questions about PF-06263726

What is PF-06263726?

PF-06263726 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.

What is PF-06263726 used for?

PF-06263726 is being studied for use in healthy subjects. The completed Phase 1 trial evaluated tolerability, safety, and pharmacokinetics of the topical formulation in healthy volunteers. It is not approved for any disease or condition.

What does PF-06263726 target?

The molecular target of PF-06263726 has not been disclosed. The available information does not specify a target or target class for this investigational small molecule.

Who makes PF-06263726?

PF-06263726 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The drug is currently in Phase 1 clinical development.

What phase is PF-06263726 in?

PF-06263726 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-06263726 in?

PF-06263726 has one completed clinical trial, NCT01981681, a Phase 1 study in healthy subjects. The trial evaluated tolerability, safety, and pharmacokinetics of topical PF-06263276, enrolled 47 participants, and was conducted in Belgium.