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PF-06700841 Immediate release

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: May 9, 2019

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03765554Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different FormulationsPHASE1 COMPLETED 8 — — Jan 7, 2019Apr 3, 2019May 9, 20191 Belgium
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of PF-06700841
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit
pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Secondary Endpoints
Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval
Pre-dose and 48 hours post-dose
Change from baseline in heart rate
Pre-dose and 48 hours post-dose
Change from baseline in blood pressure
Pre-dose and 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06700841: IR followed by MREXPERIMENTALParticipants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR)
PF-06700841: MR followed by IREXPERIMENTALParticipants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR)
Interventions
NameTypeDescription
PF-06700841 Immediate release tabletsDRUGSmall molecule tablets in immediate release form
PF-06700841 Modified release tabletsDRUGSmall molecule tablets in modified release form
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy male, and female participants between the ages of 18 and 55 years at the time of screening, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse...

Countries:Belgium
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