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Drug: PF-07817883

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 30, 2025

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06122194A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult VolunteersPHASE1 COMPLETED 12 — — Nov 23, 2023Jan 12, 2024Jan 30, 20251 Belgium
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Secondary Endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)
Number of Participants With Laboratory Test Abnormalities
From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
Number of Participants With Clinically Significant Abnormality in Vital Signs
From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period 1 formulation 1 PF-07817883EXPERIMENTALSingle oral dose of PF-07817883 tablet under fasted condition
Period 2 formulation 2 PF-07817883EXPERIMENTALSingle oral dose of PF-07817883 tablet under fasted condition
Period 3 formulation 3 PF-07817883EXPERIMENTALSingle oral dose of PF-07817883 tablet under fasted condition
Period 4 formulation 4 PF-07817883EXPERIMENTALSingle oral dose of PF-07817883 tablet under fasted condition
Interventions
NameTypeDescription
Drug: PF-07817883DRUGPF-07817883 tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG. * BMI of 16 to 32 kg/m2; and a total body weight \>45 kg *...

Countries:Belgium
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