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PF-06273340

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 4, 2015

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-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02260947Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain EndpointsPHASE1 COMPLETED 20 — — Oct 1, 2014Dec 1, 2014Feb 4, 20151 Netherlands
NCT01934738A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)PHASE1 COMPLETED 52 — — Oct 1, 2013Mar 1, 2014Mar 11, 20141 Belgium
NCT01706796A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed StatePHASE1 COMPLETED 12 — — Nov 1, 2012Jan 1, 2013Jan 24, 20131 Singapore
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Study Endpoints
Primary Endpoints
Thermal pain detection threshold
0.5 - 4 hours
Ultra-violet light sensitized pain detection threshold
0.5 - 4 hours
Pressure pain tolerance threshold
0.5 - 4 hours
Electrical pain tolerance threshold
0.5 - 4 hours
Cold pressor tolerance threshold
0.5 - 4 hours
Maximum Observed Plasma Concentration (Cmax)
14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
14 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
up to 48 h post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
up to 48 h post dose
Elimination half life
up to 48 h post dose
Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax)
0.5 - 10 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0.5 - 10 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0.5 - 10 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -
4ACTIVE_COMPARATOR -
5PLACEBO_COMPARATOR -
Group 1: Cohort 1EXPERIMENTAL -
Group 1: Cohort 2EXPERIMENTAL -
Group 1: Cohort 3EXPERIMENTAL -
Group 2: Cohort 4EXPERIMENTAL -
Group 1: Cohort 5EXPERIMENTAL -
Group 2: Cohort 6EXPERIMENTAL -
PF-06273340 Oral Solution FastedEXPERIMENTAL -
PF-06273340 Immediate Release Tablet FastedEXPERIMENTAL -
PF-06273340 Modified Release (MR1) Tablet FastedEXPERIMENTAL -
PF-06273340 Modified Release (MR2) Tablet FastedEXPERIMENTAL -
PF-06273340 Modified Release (MR1) Tablet FedEXPERIMENTAL -
PF-06273340 Modified Release (MR2) Tablet FedEXPERIMENTAL -
Interventions
NameTypeDescription
PF-06273340DRUGPF-06273340 50 mg
PregabalinDRUGPregabalin 300 mg
IbuprofenDRUGIbuprofen 600 mg
PlaceboDRUGMatching Placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical la...

Countries:NetherlandsBelgiumSingapore
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