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14C-PF-06651600

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jul 24, 2019

14C-PF-06651600 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 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

14C-PF-06651600 clinical trials

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.
Healthy VolunteersUnlock trial analytics

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 a carbon-14 radiolabeled small molecule developed by Pfizer, Inc. (ticker PFE) for use in a Phase 1 clinical study. It is a radiolabeled form of PF-06651600 used to study how the drug is absorbed, distributed, metabolized, and excreted in the human body.

Who makes 14C-PF-06651600?

14C-PF-06651600 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer conducted the clinical research on this radiolabeled compound.

What phase is 14C-PF-06651600 in?

14C-PF-06651600 is in Phase 1 clinical development. It is an investigational compound and has not been approved by the FDA. The single Phase 1 trial evaluating it has been completed.

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

14C-PF-06651600 was evaluated in one Phase 1 trial, NCT03929510, titled a 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. The trial enrolled 6 healthy male volunteers in the Netherlands and is completed.

What is 14C-PF-06651600 used for?

14C-PF-06651600 is used as a radiolabeled research compound in a Phase 1 clinical study of healthy volunteers. The study characterized its absorption, distribution, metabolism, and excretion, and evaluated the absolute oral bioavailability and fraction absorbed of PF-06651600. No therapeutic indication has been disclosed.

How many patients were in the 14C-PF-06651600 trial?

The Phase 1 trial of 14C-PF-06651600, NCT03929510, enrolled 6 participants. It was a controlled study in healthy male volunteers aged 18 years and older, conducted in the Netherlands, and it is now completed.