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PF-05105679

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Oct 3, 2011

PF-05105679 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 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

PF-05105679 clinical trials

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
Healthy VolunteersUnlock trial analytics

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?

PF-05105679 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial involving healthy adult male volunteers. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early-stage clinical development.

Who makes PF-05105679?

PF-05105679 is made and developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 clinical trial of the compound. No partnership or licensing arrangement for PF-05105679 has been disclosed.

What phase is PF-05105679 in?

PF-05105679 is in Phase 1 clinical development. Its only recorded trial, NCT01393652, was a Phase 1 study that has been completed. The compound is investigational and has not been approved by the FDA for any indication.

What clinical trials is PF-05105679 in?

PF-05105679 has been evaluated in one clinical trial, NCT01393652, titled Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679. The Phase 1 trial enrolled 32 healthy male volunteers in Belgium, was randomized, double-blind, and active-controlled, and is now completed. No active trials are ongoing.

Is PF-05105679 FDA approved?

No. PF-05105679 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. Its single completed trial, NCT01393652, studied the compound in healthy volunteers rather than in patients with a specific disease.

What was studied in the PF-05105679 Phase 1 trial?

The Phase 1 trial NCT01393652 studied single-dose escalation of PF-05105679 in healthy volunteers. It enrolled 32 male participants aged 18 years and older in Belgium. The study was randomized, double-blind, and active-controlled, and it has been completed.