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PF-08642534

Phase 1

Healthy Participant | Small molecule | Other |Pfizer, Inc.|Last Updated: May 8, 2026

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07575945A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.PHASE1 NOT YET_RECRUITING 14May 5, 2026Jul 23, 2026May 8, 20261 United States
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Study Endpoints
Primary Endpoints
PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0 to 240 hours post-dose
Secondary Endpoints
Incidence of treatment-emergent Adverse Events
Baseline up to approximately 8 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Period 1--PF-08642534EXPERIMENTALParticipants will receive a single dose of PF-08642534
Period 2--itraconazole plus PF-08642534EXPERIMENTALParticipants will receive single doses of PF-08642534) in presence of itraconazole.
Interventions
NameTypeDescription
PF-08642534DRUGParticipants will receive a single dose of PF-08642534
ItraconazoleDRUGParticipants will receive itraconazole once daily for 13 days (Day 12 to Day 24)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Generally healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG). * Body Mass Index (BMI) of 16-30 kilograms per meter squared, inclusive, and a tota...

Countries:United States
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