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

Pfizer6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Male Subjects

Interventions

Oral PF-06700841 containing 14C microtracerDRUG

Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period

Oral unlabeled PF-06700841DRUG

60 mg unlabeled PF-06700841 oral dose in 2nd period

IV 14C-labeled PF-06700841DRUG

30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

PRA Health Sciences

Groningen, Netherlands

PRA Health Sciences Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

mass balance_urine

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

Time frame: hour 0 up to 312 hours post dose

mass balance_feces

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

Time frame: hour 0 up to 312 hours post dose

Secondary Outcomes

metabolite identification_plasma

metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

plasma Cmax for total 14C radioactivity

maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

plasma Tmax for total 14C radioactivity

time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

plasma AUClast for total 14C radioactivity

area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

plasma AUCinf for total 14C radioactivity

area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841

Data from ClinicalTrials.gov

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Time frame: hour 0 up to 312 hours post dose

Oral clearance for total 14C radioactivity

oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

plasma half-life for total 14C radioactivity

half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

volume of distribution for total 14C radioactivity

apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841

Time frame: hour 0 up to 312 hours post dose

plasma Cmax for PF-06700841

maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841