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PF-05212372

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Aug 15, 2011

PF-05212372 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

PF-05212372 clinical trials

PF-05212372 · 1 trial · 5 indications

Phase 1 1
NCT01415102A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.Phase 1
COMPLETED24 Analytics
PHASE1COMPLETED
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
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Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
14 days
Plasma pharmacokinetics
up to 72 hours post dose
Urine pharmacokinetics
up to 24 hours post dose
Urine Pharmacodynamics
up to 24 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSubjects will be assigned to receive either PF-05212372 or placebo in each period
Cohort 2EXPERIMENTALSubjects will be assigned to receive either PF-05212372 or placebo in each period

Interventions

NameTypeDescription
PF-05212372DRUGInhaled. Dose Level 1: 50 ug
PlaceboDRUGInhaled
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Exclusion Criteria: * Evidence or...

Countries:Belgium
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Frequently asked questions about PF-05212372

What is PF-05212372?

PF-05212372 is an investigational small molecule drug developed by Pfizer, Inc. It was studied as an inhaled therapy in a first-in-human Phase 1 trial in healthy volunteers. The compound has not been approved, and its intended disease indication has not been publicly disclosed.

Who is developing PF-05212372?

PF-05212372 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the single Phase 1 study of the compound. No partner or collaborator is identified for this asset.

What phase is PF-05212372 in?

PF-05212372 is in Phase 1 development. It has completed one first-in-human study, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA or any other regulator for any indication.

What clinical trials is PF-05212372 in?

PF-05212372 has been studied in one completed Phase 1 trial, NCT01415102. That first-in-human study enrolled 24 healthy volunteers in Belgium and evaluated safety, toleration, and the time course of plasma concentration after single inhaled doses. It was randomized, double-blind, and controlled.

How was PF-05212372 administered in its clinical trial?

PF-05212372 was given as single inhaled doses in its Phase 1 trial, NCT01415102. The study assessed safety, toleration, and plasma concentration over time in 24 healthy adult volunteers aged 18 years and older in Belgium. It used a randomized, double-blind, controlled design.