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PF-06427878

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 14, 2018

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02410525A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography ScanningPHASE1 COMPLETED 8 — — May 1, 2015Sep 1, 2015Oct 29, 20153 United States
NCT02237742A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, MalesPHASE1 COMPLETED 6 — — Nov 1, 2014Dec 1, 2014Nov 14, 20181 United Kingdom
NCT02208284A Single Oral Dose Study Of PF-06427878 In Healthy Adult SubjectsPHASE1 COMPLETED 16 — — Aug 1, 2014Dec 1, 2014Mar 4, 20151 United States
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Study Endpoints
Primary Endpoints
Percent injected radioactivity (per gram) over time in the liver
All Periods;Day 1;0-120min
Percent injected radioactivity (per gram) over time in the plasma
All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)
Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Maximum Observed Plasma Concentration (Cmax)
Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Terminal Elimination Half Life (t1/2)
Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Systemic Clearance (CL)
Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Plasma Volume of Distribution at Steady State (Vss)
Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Assessment of adverse events (AEs).
0-48 h post dose
Assessment of clinical laboratory tests.
0-48 h post dose
Assessment of vital signs (including blood pressure and pulse rate).
0-48 h post dose
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
0-48 h post dose
Secondary Endpoints
Relative radioactivity in liver versus plasma
All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable
All Periods;Day 1;0-2hr
% of parent in plasma over time
All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[11C]PF-06427878EXPERIMENTALSingle intravenous infusion of \[11C\]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability
PF-06427878 10 mgEXPERIMENTALSingle oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability
PF-06427878 600 mgEXPERIMENTALSingle oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability
PF-06427878EXPERIMENTAL -
Cohort 1-PF-06427878 or placeboEXPERIMENTALSingle ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Cohort 2-PF-06427878 or placeboEXPERIMENTALSingle ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Cohort 3-PF-06427878 or placeboEXPERIMENTALSingle ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Interventions
NameTypeDescription
[11C]PF-06427878DRUGSingle administration via intravenous infusion of 20 ug \[11C\]PF-06427878 on Day 1 of all 3 Periods
PF-06427878 10 mgDRUGSingle oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to \[11C\]PF-06427878 administration
PF-06427878 600 mgDRUGSingle oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to \[11C\]PF-06427878 administration
PF-06427878DRUGIntravenous, 100 micrograms, single dose, 30 minute infusion
PlaceboDRUGPF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * healthy males * body mass index 17.5-30.5 kg/m2 ; body weight \>50 kg * signed and dated informed consent document * willing and able to comply with study requirements Exclusion Criteria: * tobacco/nicotine containing products \> equivalent of 5 cigarettes per day * history ...

Countries:United StatesUnited Kingdom
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