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PF-06954522 IR

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 8, 2024

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 Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06393517A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy AdultsPHASE1 COMPLETED 23 — — Apr 30, 2024Sep 1, 2024Oct 8, 20242 United States
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Study Endpoints
Primary Endpoints
Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.
0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period
Secondary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (AEs)
From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1
Number of Participants with Laboratory Test Abnormalities
From baseline up to 72 hours after PF-06954522 dose in each period
Number of Participants with Summary of Post-Baseline Vital Signs Data
From baseline up to 72 hours after PF-06954522 dose in each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
Sequence 2EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
Sequence 3EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively.
Sequence 4EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
Sequence 5EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
Sequence 6EXPERIMENTALParticipants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively.
Interventions
NameTypeDescription
PF-06954522 IR (Formulation 1)DRUGParticipants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth
PF-06954522 MR (Formulation 2)DRUGParticipants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.
PF-06954522 MR (Formulation 3)DRUGParticipants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms. * Body mass index of 16-32 kg/m...

Countries:United States
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