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14C-PF-06826647-LR

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials 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

14C-PF-06826647-LR clinical trials

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
HealthyUnlock trial analytics

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?

14C-PF-06826647-LR is a carbon-14 radiolabeled small molecule developed by Pfizer, Inc. (PFE). It is an investigational drug candidate that has been studied in a Phase 1 clinical trial to assess its mass balance and absolute bioavailability in healthy male participants. The specific therapeutic indication for this drug has not been disclosed.

Who is developing 14C-PF-06826647-LR?

14C-PF-06826647-LR is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sole sponsor of the clinical program for this investigational small molecule.

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

14C-PF-06826647-LR is in Phase 1 clinical development. The single Phase 1 trial for this drug has been completed. It is an investigational agent and has not been approved by the FDA for any indication.

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

14C-PF-06826647-LR has been studied in one completed Phase 1 clinical trial, NCT04591262, titled "A Study To Assess Mass Balance And Absolute Bioavailability Of 14C PF-06826647 In Healthy Male Participants." The trial enrolled 6 healthy male participants in the Netherlands and was an uncontrolled, non-randomized study.