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PF-06263726

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jul 17, 2014

PF-06263726 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2013

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

PF-06263726 clinical trials

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 developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial conducted in healthy adult volunteers in Belgium. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing PF-06263726?

PF-06263726 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 clinical study of the compound. No partnership or licensing arrangement for this asset has been announced.

What phase is PF-06263726 in?

PF-06263726 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as being in any active trial. It is an investigational agent and is not approved by the FDA for any indication.

What clinical trials has PF-06263726 been studied in?

PF-06263726 has been evaluated in one completed Phase 1 trial, NCT01981681, titled a Phase 1 study to evaluate tolerability, safety, and pharmacokinetics of topical PF-06263276 in healthy subjects. The trial enrolled 47 participants in Belgium, was randomized, double blind, and placebo controlled.

What is PF-06263726 used for?

The therapeutic use of PF-06263726 has not been disclosed. The compound has only been studied in a Phase 1 trial in healthy volunteers, which assessed tolerability, safety, and pharmacokinetics rather than efficacy in a patient population. No approved indication exists for this investigational small molecule.