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Drug: PF-07923568

Phase 1

Renal Impairment | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Jul 19, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06037031A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney FunctionPHASE1 COMPLETED 16 — — Oct 30, 2023Jul 3, 2024Jul 19, 20246 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Baseline through Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Baseline through Day 5
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Baseline through Day 5
Secondary Endpoints
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Baseline through Day 36
Number of Participants With Change From Baseline in Laboratory Tests Results
Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline through Day 5
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1: Severe Renal ImpairmentEXPERIMENTALParticipants with severe renal impairment will receive a single oral dose of PF-07923568
Cohort 2: Normal Renal FunctionEXPERIMENTALParticipants with normal renal function will receive a single oral dose of PF-07923568
Cohort 3 (Optional): Moderate Renal ImpairmentEXPERIMENTALParticipants with moderate renal impairment will receive a single oral dose of PF-07923568
Interventions
NameTypeDescription
Drug: PF-07923568DRUGA single dose of PF-07923568 administered orally as 4 capsules
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: 1. Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening. 2. Meet the eGFR criteria for cohort placement during the screening period. 3. Body mass index (BMI) of 16-40 kg/m2; and a total b...

Countries:United States
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