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NCT03770039 Clinical Trial

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

Healthy Male Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03770039
Other study ID # B7931014
Secondary ID 2018-002403-34
Status Completed
Phase Phase 1
First received
Last updated
Start date December 10, 2018
Est. completion date February 21, 2019

Study information
Verified date March 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date February 21, 2019
Est. primary completion date February 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral PF-06700841 containing 14C microtracer
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-06700841
60 mg unlabeled PF-06700841 oral dose in 2nd period
• IV 14C-labeled PF-06700841
30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

Locations
Country Name City State
Netherlands PRA Health Sciences Groningen
Netherlands PRA Health Sciences Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary mass balance_urine cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered hour 0 up to 312 hours post dose
Primary mass balance_feces cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered hour 0 up to 312 hours post dose
Secondary metabolite identification_plasma metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841 hour 0 up to 312 hours post dose
Secondary plasma Cmax for total 14C radioactivity maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841 hour 0 up to 312 hours post dose
Secondary plasma Tmax for total 14C radioactivity time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841 hour 0 up to 312 hours post dose
Secondary 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 hour 0 up to 312 hours post dose
Secondary 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 hour 0 up to 312 hours post dose
Secondary Oral clearance for total 14C radioactivity oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841 hour 0 up to 312 hours post dose
Secondary 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 hour 0 up to 312 hours post dose
Secondary 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 hour 0 up to 312 hours post dose
Secondary plasma Cmax for PF-06700841 maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma Tmax for PF-06700841 time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma AUClast for PF-06700841 area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma AUCinf for PF-06700841 area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary Oral clearance for PF-06700841 oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma half-life for PF-06700841 half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary volume of distribution for PF-06700841 apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma Cmax for 14C-labeled PF-06700841 maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma Tmax for 14C-labeled PF-06700841 time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma AUClast for 14C-labeled PF-06700841 area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma AUCinf for 14C-labeled PF-06700841 area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary clearance for 14C-labeled PF-06700841 clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary plasma half-life for 14C-labeled PF-06700841 half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary volume of distribution for 14C-labeled PF-06700841 volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841 hour 0 up to 96 hours post dose
Secondary unchanged PF-06700841 recovered in urine percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841 hour 0 up to 96 hours post dose
Secondary renal clearance of PF-06700841 renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841) hour 0 up to 96 hours post dose
Secondary Bioavailability of oral PF-06700841 Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841 hour 0 up to 96 hours post dose
Secondary Fraction absorbed of oral PF-06700841 Fraction absorbed in gut (Fa) following oral dose of PF-06700841 hour 0 up to 144 hours post dose
Secondary metabolite identification_urine metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841 hour 0 up to 312 hours post dose
Secondary metabolite identification_feces metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841 hour 0 up to 312 hours post dose
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