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PF-06865571 in Fed State

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 27, 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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04044053Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult ParticipantsPHASE1 COMPLETED 12Aug 13, 2019Oct 31, 2019Nov 27, 20191 Belgium
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Study Endpoints
Primary Endpoints
Single Dose Maximum Observed Plasma Concentration (Cmax) of PF-06865571 in Healthy Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose

All study participants

Single Dose Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06865571 in Healthy Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose

All study participants

Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(last)] of PF-06865571 in Healthy Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose

All study participants

Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)] of PF-06865571 in Healthy Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose

All study participants

Secondary Endpoints
Single Dose Cmax of PF-06865571 in Healthy Japanese Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose
Single Dose Tmax of PF-06865571 in Healthy Japanese Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose
Single Dose AUC(last) of PF-06865571 in Healthy Japanese Participants
Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Relative BioavailabilityEXPERIMENTALEach participant will receive 400 mg IR, 400 mg MR, and 50 mg MR in the fed state, and 400 mg MR in the fasted state
Fasted StateEXPERIMENTALComparison of 400 mg MR in fed and fasted states
Interventions
NameTypeDescription
PF-06865571 400 mg Immediate Release (IR) in Fed StateDRUG400 mg IR dose in fed state
PF-06865571 50 mg Modified Release (MR) in Fed StateDRUG50 mg MR in fed state
PF-06865571 400 mg MR in Fed StateDRUG400 mg MR in fed state
PF-06865571 400 mg MR in Fasted StateDRUG400 mg MR in fasted state
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total ...

Countries:Belgium
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