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14C-PF-06651600

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

14C-PF-06651600 · 1 trial · 1 indication

Phase 1 1
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.Healthy Volunteers
COMPLETED6 Analytics
PHASE1COMPLETED
Study to Characterize Absorption, Distribution, Metabolism and Excretion of 14C PF-06651600 and to Evaluate the Absolute Oral Bioavailability and Fraction Absorbed of PF-06651600.
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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 to 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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Frequently asked questions about 14C-PF-06651600

What is 14C-PF-06651600?

14C-PF-06651600 is an investigational small molecule being developed by Pfizer, Inc. It is a radiolabeled form of PF-06651600, used in a Phase 1 clinical trial to study its absorption, distribution, metabolism, and excretion in healthy volunteers. The drug is not approved and remains in clinical development.

What is 14C-PF-06651600 used for?

14C-PF-06651600 is used in a Phase 1 clinical trial to characterize the absorption, distribution, metabolism, and excretion of the drug, and to evaluate its absolute oral bioavailability and fraction absorbed. The study involves healthy male volunteers in the Netherlands.

Who makes 14C-PF-06651600?

14C-PF-06651600 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is 14C-PF-06651600 in?

14C-PF-06651600 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed.

What clinical trials is 14C-PF-06651600 in?

14C-PF-06651600 has one completed Phase 1 clinical trial, identified as NCT03929510. This study, conducted in the Netherlands, enrolled 6 healthy male volunteers aged 18 years and older to evaluate the drug's absorption, distribution, metabolism, excretion, and absolute oral bioavailability.

Is 14C-PF-06651600 the same as PF-06651600?

14C-PF-06651600 is a radiolabeled form of PF-06651600, used in clinical studies to track the drug's behavior in the body. The 14C label allows researchers to characterize the absorption, distribution, metabolism, and excretion of PF-06651600.