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PF-06700841 containing 14C microtracer

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Mar 6, 2019

PF-06700841 containing 14C microtracer target and mechanism

ModalitySmall molecule

Also known as Oral PF-06700841 containing 14C microtracer

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

PF-06700841 containing 14C microtracer clinical trials

PF-06700841 containing 14C microtracer · 1 trial · 1 indication

Phase 1 1
NCT03770039Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male SubjectsHealthy Male Subjects
COMPLETED6 Analytics
PHASE1COMPLETED
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
Healthy Male SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

mass balance_urine
hour 0 up to 312 hours post dose

cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered

mass balance_feces
hour 0 up to 312 hours post dose

cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered

Secondary Endpoints

metabolite identification_plasma
hour 0 up to 312 hours post dose
plasma Cmax for total 14C radioactivity
hour 0 up to 312 hours post dose
plasma Tmax for total 14C radioactivity
hour 0 up to 312 hours post dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
2-period, fixed sequenceEXPERIMENTALfixed sequence with 2 treatment period

Interventions

NameTypeDescription
Oral PF-06700841 containing 14C microtracerDRUGOral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
Oral unlabeled PF-06700841DRUG60 mg unlabeled PF-06700841 oral dose in 2nd period
IV 14C-labeled PF-06700841DRUG30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Exclusion Criteria: * Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection). * Total 14C radioactivity measured in plasma exceeding 11 mBq/mL * History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test * Use of ...

Countries:Netherlands
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Frequently asked questions about PF-06700841 containing 14C microtracer

What is PF-06700841 containing 14C microtracer?

PF-06700841 containing 14C microtracer is an oral small molecule developed by Pfizer, Inc. (NYSE: PFE). It combines an unlabeled dose of PF-06700841 with a carbon-14 labeled microdose, a technique used in early clinical research to study how a drug is absorbed, distributed, metabolized, and excreted in the body.

Who makes PF-06700841 containing 14C microtracer?

Pfizer, Inc. (ticker PFE) is the developer of PF-06700841 containing 14C microtracer. The compound was studied in a single Phase 1 trial conducted by Pfizer, and no other sponsors or partners are associated with this microtracer formulation.

What phase is PF-06700841 containing 14C microtracer in?

PF-06700841 containing 14C microtracer is in Phase 1 development. It is an investigational agent and has not been approved by the FDA. The only recorded trial, NCT03770039, is a completed Phase 1 study, and no active trials of this microtracer formulation are ongoing.

What clinical trial is PF-06700841 containing 14C microtracer in?

PF-06700841 containing 14C microtracer was evaluated in one completed Phase 1 trial, NCT03770039, titled Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects. The study enrolled 6 healthy male volunteers aged 18 years and older in the Netherlands.

Is PF-06700841 containing 14C microtracer the same as oral PF-06700841 containing 14C microtracer?

Yes. PF-06700841 containing 14C microtracer is also known as oral PF-06700841 containing 14C microtracer. Both names refer to the same Pfizer small molecule formulation that pairs an unlabeled dose with a carbon-14 labeled microdose for human absorption, metabolism, and excretion research.

How was the PF-06700841 containing 14C microtracer trial designed?

NCT03770039 was an uncontrolled, open-label Phase 1 study, not randomized and not double blinded. It enrolled 6 healthy male subjects in the Netherlands and has been completed. The trial used a single unlabeled dose together with a 14C-labeled microdose of PF-06700841.