Clinical trial NCT03770039: Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
Official title: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Keywords: PF-06700841
mass balance
metabolites
absolute bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: mass balance_urine
timeFrame: hour 0 up to 312 hours post dose
measure: mass balance_feces
timeFrame: hour 0 up to 312 hours post dose
Secondary outcomes:
measure: metabolite identification_plasma
timeFrame: hour 0 up to 312 hours post dose
measure: plasma Cmax for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: plasma Tmax for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: plasma AUClast for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: plasma AUCinf for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: Oral clearance for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: plasma half-life for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: volume of distribution for total 14C radioactivity
timeFrame: hour 0 up to 312 hours post dose
measure: plasma Cmax for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma Tmax for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma AUClast for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma AUCinf for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: Oral clearance for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma half-life for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: volume of distribution for PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma Cmax for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma Tmax for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma AUClast for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma AUCinf for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: clearance for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: plasma half-life for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: volume of distribution for 14C-labeled PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: unchanged PF-06700841 recovered in urine
timeFrame: hour 0 up to 96 hours post dose
measure: renal clearance of PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: Bioavailability of oral PF-06700841
timeFrame: hour 0 up to 96 hours post dose
measure: Fraction absorbed of oral PF-06700841
timeFrame: hour 0 up to 144 hours post dose
measure: metabolite identification_urine
timeFrame: hour 0 up to 312 hours post dose
measure: metabolite identification_feces
timeFrame: hour 0 up to 312 hours post dose
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
city: Utrecht
country: Netherlands
facility: PRA Health Sciences Utrecht
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: