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14C-PF-06651600

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 24, 2019

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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03929510Study to Characterize Absorption, Distribution, Metabolism and Excretion of 14C PF-06651600 and to Evaluate the Absolute Oral Bioavailability and Fraction Absorbed of PF-06651600.PHASE1 COMPLETED 6 — — Apr 23, 2019Jul 5, 2019Jul 24, 20192 Netherlands
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Study Endpoints
Primary Endpoints
Mass Balance: Cumulative recovery (%) of radioactivity in urine
from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24

Cumulative recovery (%) of radioactivity in urine.

Mass Balance: Cumulative recovery (%) of radioactivity in feces
from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24

Cumulative recovery (%) of radioactivity in feces

Secondary Endpoints
Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma
Hour 0 up to 312 hours post-dose.
Amount (% of the administered dose) of major metabolites of PF-06651600 in urine
Hour 0 up to 312 hours post-dose.
Amount (% of the administered dose) of major metabolites of PF-06651600 in feces
Hour 0 up to 312 hours post-dose.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Period AEXPERIMENTALSingle oral dose of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF 06651600).
Period BEXPERIMENTALSingle oral dose of 200 milligrams (mg) unlabeled PF-06651600 followed at time of peak plasma concentration (Tmax) by an Intravenous (IV) dose of 60 micrograms.14C -PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF-06651600).
Interventions
NameTypeDescription
14C-PF-06651600DRUGOral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
14C-PF-06651600 IVDRUGIV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
PF-06651600DRUGOral solution 200mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male participants who are healthy as determined by medical evaluation including a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead ECG, and clinical laboratory tests. * Body mass index (BMI) of 17.5 to ...

Countries:Netherlands
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