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PF-07923568

Phase 1

Liver Diseases | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Mar 21, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05857644A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.PHASE1 COMPLETED 28 — — Jun 7, 2023Feb 7, 2024Mar 21, 20253 United States
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Study Endpoints
Primary Endpoints
Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

Cmax was the highest concentration observed directly from data

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sisunatovir Following Administration of a Single Oral Dose
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

AUClast was determined using linear/Log trapezoidal method

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6

AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminalphase rate constant.

Secondary Endpoints
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Day -1 through follow-up (Day 29-36)
Number of Participants With Laboratory Test Abnormalities
Day -1 and Day 6
Number of Participants With Vital Signs Meeting Categorical Criteria
Day -1, Day 1, Day 2, and Day 6
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Healthy subjectsEXPERIMENTALOne time dose of 4 capsules taken orally.
Mild Hepatic impaired subjectsEXPERIMENTALOne time dose of 4 capsules taken orally.
Moderate hepatic impaired subjectsEXPERIMENTALOne time dose of 4 capsules taken orally
Severe Hepatic Impaired SubjectsEXPERIMENTALOne time dose of 4 capsules taken orally.
Interventions
NameTypeDescription
PF-07923568DRUGOne time dose of 4 capsules taken orally.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: for healthy volunteers: * BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lb). * Capable of giving signed informed consent. * At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, in...

Countries:United States
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