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PF-06700841 containing 14C microtracer

Phase 1

Healthy Male Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 6, 2019

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

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 used for?

PF-06700841 containing 14C microtracer is an investigational small molecule being studied in healthy male subjects. It is used in a Phase 1 clinical trial to evaluate the absorption, metabolism, and excretion of the drug using a radioactive 14C-labeled microdose. The study is not designed to treat any disease.

Who makes PF-06700841 containing 14C microtracer?

PF-06700841 containing 14C microtracer is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.

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

PF-06700841 containing 14C microtracer is in Phase 1 clinical development. It is an investigational drug and is not approved by regulatory authorities. The single Phase 1 trial has been completed.

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

PF-06700841 containing 14C microtracer has one completed clinical trial, registered as NCT03770039. The trial, titled "Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects," enrolled 6 participants in the Netherlands and was not randomized or blinded.

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

PF-06700841 containing 14C microtracer is a formulation of PF-06700841 that includes a 14C-labeled microdose, used to track the drug's behavior in the body. The trial combines an unlabeled dose with a 14C-labeled microdose to study how the drug is processed.