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PF-05105679

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 3, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

PF-05105679 · 1 trial · 1 indication

Phase 1 1
NCT01393652Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679Healthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
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Study Endpoints

Primary Endpoints

Number of participants with adverse events as a measure of safety and tolerability.
3 days
Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT
3 days

Secondary Endpoints

Average AUC2min VAS (cold pressor test) of PF-05105679.
24 hours
Cold detection threshold (°C) of PF-05105679.
24 hours
Cold pain threshold (°C) of PF-05105679.
24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1: Experimental intervention: PF-05105679 or placeboEXPERIMENTALCohort 1
Cohort 2: Experimental intervention: PF-05105679 or placeboEXPERIMENTALCohort 2
Cohort 3: Experimental intervention PF-05105679 or placebo andACTIVE_COMPARATORCohort 3

Interventions

NameTypeDescription
PF-05105679DRUGSubjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy Volunteers Exclusion Criteria: Standard Healthy Volunteers

Countries:Belgium
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Frequently asked questions about PF-05105679

What is PF-05105679 used for?

PF-05105679 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess its safety, tolerability, and pharmacokinetics following single ascending doses. The drug is not approved for any indication and remains in early clinical development.

Who makes PF-05105679?

PF-05105679 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial of the drug in healthy volunteers.

What phase is PF-05105679 in?

PF-05105679 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is a single-dose, dose-escalation study in healthy volunteers.

What clinical trials is PF-05105679 in?

PF-05105679 is being studied in one completed Phase 1 clinical trial, NCT01393652, titled 'Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679.' The trial enrolled 32 healthy male participants in Belgium and was active-controlled and double-blinded.

Is PF-05105679 the same as any other drug?

No alternative names for PF-05105679 have been disclosed. The drug is identified solely by its compound number PF-05105679 in clinical trial records.