Recent Updates
Recently added Catalysts

PF-06865571 Immediate release

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 17, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03372044A Study To Evaluate Different Formulations Of PF-06865571 In Healthy SubjectsPHASE1 COMPLETED 12 — — Jan 19, 2018Apr 4, 2018Apr 17, 20181 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Time to Reach Maximum Observed Concentration for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).

Plasma Decay Half-Life (t1/2) for PF-06865571
0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period

Plasma Decay Half-Life (t1/2)

Secondary Endpoints
Number of subjects with adverse events (AEs)
Baseline up to 35 days after last dose
Number of subjects with laboratory tests findings of potential clinical importance
Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Baseline (Day 0) up to 48 hours after last dose of study medication
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06865571EXPERIMENTALTreatment
Interventions
NameTypeDescription
PF-06865571 Immediate release suspensionDRUGSuspension
PF-06865571 Slow release MR tabletsDRUGModified release tablets
PF-06865571 Fast release MR tabletsDRUGModified release tablets
PF-06865571 Immediate release tabletsDRUGImmediate release tablets
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males and female of non-childbearing potential * Age of 18-55, inclusive * Body Mass Index 17.5 to 30.5 kg/m2, inclusive * Body weight \>50 kg * Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose. Exclusion Criteria: *...

Countries:Belgium
Unlock Eligibility Criteria