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OpenTrials
Completed

NCT Number: NCT03770039

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

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

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Key information

Conditions

Healthy Male Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral PF-06700841 containing 14C microtracer

Drug

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

Drug

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

IV 14C-labeled PF-06700841

Drug

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

Primary outcomes

  1. mass balance_urine

    Time frame: hour 0 up to 312 hours post dose

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

  2. mass balance_feces

    Time frame: hour 0 up to 312 hours post dose

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

Secondary outcomes

  1. metabolite identification_plasma

    Time frame: hour 0 up to 312 hours post dose

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

  2. plasma Cmax for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  3. plasma Tmax for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  4. plasma AUClast for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  5. plasma AUCinf for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  6. Oral clearance for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  7. plasma half-life for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  8. volume of distribution for total 14C radioactivity

    Time frame: hour 0 up to 312 hours post dose

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

  9. plasma Cmax for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  10. plasma Tmax for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  11. plasma AUClast for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    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

  12. plasma AUCinf for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    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

  13. Oral clearance for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  14. plasma half-life for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  15. volume of distribution for PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  16. plasma Cmax for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841

  17. plasma Tmax for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  18. plasma AUClast for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    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

  19. plasma AUCinf for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  20. clearance for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841

  21. plasma half-life for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

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

  22. volume of distribution for 14C-labeled PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841

  23. unchanged PF-06700841 recovered in urine

    Time frame: hour 0 up to 96 hours post dose

    percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841

  24. renal clearance of PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)

  25. Bioavailability of oral PF-06700841

    Time frame: hour 0 up to 96 hours post dose

    Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841

  26. Fraction absorbed of oral PF-06700841

    Time frame: hour 0 up to 144 hours post dose

    Fraction absorbed in gut (Fa) following oral dose of PF-06700841

  27. metabolite identification_urine

    Time frame: hour 0 up to 312 hours post dose

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

  28. metabolite identification_feces

    Time frame: hour 0 up to 312 hours post dose

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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