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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: IV 14C-labeled PF-06700841

Drug: Oral unlabeled PF-06700841

Drug: Oral PF-06700841 containing 14C microtracer

Study type

Interventional

Funder types

Industry

Identifiers

NCT03770039

B7931014

2018-002403-34 (EudraCT Number)

Details and patient eligibility

About

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract

Enrollment

6 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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 <90 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.