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14C-PF-06826647-LR

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 21, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04591262A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male ParticipantsPHASE1 COMPLETED 6Nov 10, 2020Jan 28, 2021Feb 21, 20212 Netherlands
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Study Endpoints
Primary Endpoints
Total radioactivity in urine and feces together expressed as percent of total oral radioactive dose
Up to Day 14
Secondary Endpoints
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Up to Day 28
Number of participants with abnormal ECG
Up to Day 28
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Up to Day 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
PF-06826647 600 mg PO>PF-06826647 600 mg PO+100 ug IVEXPERIMENTALPF-06826647 600 mg single dose in Period 1 followed by PF-06826647 600 mg PO and IV infusion of 100 ug of PF-06826647 in Period 2.
Interventions
NameTypeDescription
14C-PF-06826647-LR 600 mg PODRUG14C-PF-06826647-LR 600 mg with 300 nCi orally as extemp prep
PF-06826647 600 mg PODRUGUnlabeled PF-06826647 600 mg
14C-PF-06826647 100 ug IVDRUG14C-PF-06826647 100 ug IV
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy Male participants must be 18 to 55 years of age, inclusive. * Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including BP and pulse rate measurement, laboratory tests, and 12 lead ECG. * Pa...

Countries:Netherlands
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