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PF-04418948

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 25, 2010

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

Clinical trial landscape

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
Healthy
NCT0100296356
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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 used for?

PF-04418948 is an investigational small molecule being studied for use in healthy volunteers. It is not approved for any disease or condition and is in clinical development to assess its safety and tolerability.

Who makes PF-04418948?

PF-04418948 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants.

What phase is PF-04418948 in?

PF-04418948 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is PF-04418948 in?

PF-04418948 has one completed Phase 1 trial, NCT01002963, which investigated the safety and toleration of a single dose in healthy volunteers. The trial enrolled 56 male participants in Belgium.

Is PF-04418948 the same as any other drug?

PF-04418948 is a unique investigational compound and is not known to be the same as any other marketed drug. It is being studied under this identifier by Pfizer.