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PF-07940367

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 13, 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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06190561A Study to Learn How Different Products of the Study Medicine Called PF-07940367 Are Taken up Into the Blood in Healthy AdultsPHASE1 COMPLETED 40 — — Jan 15, 2024May 7, 2024Jun 13, 20241 United States
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Study Endpoints
Primary Endpoints
Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to 336 hours (AUC336) of PF-07940367 dose to evaluate pharmacokinetic comparability of two PF-07940367 products
0 hours (pre-dose) to 336 hours post-PF-07940367 dose
Secondary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs)
From baseline up to 56 days after PF-07940367 dose
Number of Participants With Clinically Significant Laboratory Abnormalities
From baseline up to 336 hours after PF-07940367 dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
From baseline up to 96 hours after PF-07940367 dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A: PF-07940367 Product IIEXPERIMENTALtablet by mouth
Treatment B: PF-07940367 Product IEXPERIMENTALtablet by mouth
Interventions
NameTypeDescription
PF-07940367DRUGParticipants to receive a single dose of PF-07940367 product II 150 mg by mouth
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * BMI of 16-32 kg/m2; and a total body weight \>50 kg (110 lb). * Willing and able to comply with...

Countries:United States
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