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PF-05105679

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01393652Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679PHASE1 COMPLETED 32 — — May 1, 2011Sep 1, 2011Oct 3, 20111 Belgium
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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 — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy Volunteers Exclusion Criteria: Standard Healthy Volunteers

Countries:Belgium
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