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PF-04418948

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Oct 25, 2010

PF-04418948 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

PF-04418948 clinical trials

PF-04418948 · 1 trial · 1 indication

Phase 1 1
NCT01002963A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy VolunteersHealthy
COMPLETED56 Analytics
PHASE1COMPLETED
A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2
240 hours
Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine).
240 hours

Secondary Endpoints

Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level.
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-04418948 30 mgEXPERIMENTAL -
PF-04418948 100 mgEXPERIMENTAL -
PF-04418948 300 mgEXPERIMENTAL -
PF-04418948 1000 mgEXPERIMENTAL -
PF-04418948 3000 mgEXPERIMENTAL -
PF-04418948 4500 mgEXPERIMENTAL -
PF-04418948 6000 mgEXPERIMENTAL -

Interventions

NameTypeDescription
PF-04418948DRUGsolution, 30 mg, single
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointest...

Countries:Belgium
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Frequently asked questions about PF-04418948

What is PF-04418948?

PF-04418948 is an investigational small molecule developed by Pfizer, Inc. It has been studied in a Phase 1 clinical trial in healthy adult male volunteers. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.

Who makes PF-04418948?

PF-04418948 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound conducted in Belgium. No partnership or licensing arrangement for PF-04418948 has been announced.

What phase is PF-04418948 in?

PF-04418948 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The only recorded trial was a completed Phase 1 study, and no active trials are currently listed for this compound.

What clinical trials is PF-04418948 in?

PF-04418948 has been evaluated in one clinical trial, NCT01002963, titled A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers. The Phase 1 trial enrolled 56 healthy male volunteers in Belgium, was randomized, double-blind, and controlled, and is now completed.

What was the design of the PF-04418948 Phase 1 trial?

The Phase 1 trial of PF-04418948, NCT01002963, was a randomized, double-blind, controlled study of a single dose in healthy volunteers. It enrolled 56 male participants aged 18 years and older in Belgium. The trial assessed safety and toleration and has been completed.