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14C-PF-06826647-LR

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

14C-PF-06826647-LR · 1 trial · 1 indication

Phase 1 1
NCT04591262A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male ParticipantsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants
Healthy
NCT045912626
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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 to 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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Frequently asked questions about 14C-PF-06826647-LR

What is 14C-PF-06826647-LR used for?

14C-PF-06826647-LR is an investigational small molecule being studied in healthy volunteers. It is a radiolabeled form of PF-06826647, used in a Phase 1 clinical trial to assess mass balance and absolute bioavailability. The drug is not approved and remains in clinical development.

Who makes 14C-PF-06826647-LR?

14C-PF-06826647-LR is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational small molecule.

What phase is 14C-PF-06826647-LR in?

14C-PF-06826647-LR is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is 14C-PF-06826647-LR in?

14C-PF-06826647-LR has one completed clinical trial, registered as NCT04591262. This Phase 1 study, titled 'A Study To Asses Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants,' enrolled 6 healthy male participants in the Netherlands.

Is 14C-PF-06826647-LR the same as PF-06826647?

14C-PF-06826647-LR is a radiolabeled version of PF-06826647, used in clinical research to track the drug's absorption, distribution, metabolism, and excretion. The 14C label indicates the presence of carbon-14, a radioactive isotope, which allows researchers to study the drug's behavior in the body.