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Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

Last updated on March 14, 2019

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Study Location
PRA Health Sciences
Groningen, , 9728 NZ Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Male Subjects
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 tobacoo/nicotine containing products 3-m prior to dosing or positive urine
cotinine test

- Use of herbal supplements within 28 days prior to the first dose of study medication

- Use of prescription or nonprescription drugs (including vitamins and dietary
supplements) within 7 days or 5 half?lives (whichever is longer) prior to the first
dose of study medication. As an exception, acetaminophen may be used at doses of 1
g/day. Limited use of non?prescription medications that are not believed to affect
subject safety or the overall results of the study may be permitted on a case?by?case
basis following approval by Pfizer

- Inability to have at least one bowel movement every 2 days on average eGFR of mL/mim/1.73 m2 based on MDRD equation

- Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to
the first dose of investigational product, or expects to be vaccinated with these
vaccines during study treatment, or within the 6 weeks following the last dose of
investigational product.

NCT03770039
Pfizer
Completed
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

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