<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770039</url>
  </required_header>
  <id_info>
    <org_study_id>B7931014</org_study_id>
    <secondary_id>2018-002403-34</secondary_id>
    <nct_id>NCT03770039</nct_id>
  </id_info>
  <brief_title>Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with&#xD;
      14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841&#xD;
      followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after&#xD;
      oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion&#xD;
      of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI&#xD;
      tract&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">February 21, 2019</completion_date>
  <primary_completion_date type="Actual">February 21, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mass balance_urine</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mass balance_feces</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>metabolite identification_plasma</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma Cmax for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma Tmax for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma AUClast for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma AUCinf for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral clearance for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma half-life for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volume of distribution for total 14C radioactivity</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma Cmax for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma Tmax for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma AUClast for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma AUCinf for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral clearance for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma half-life for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volume of distribution for PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma Cmax for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma Tmax for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma AUClast for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma AUCinf for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clearance for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma half-life for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volume of distribution for 14C-labeled PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>unchanged PF-06700841 recovered in urine</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal clearance of PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioavailability of oral PF-06700841</measure>
    <time_frame>hour 0 up to 96 hours post dose</time_frame>
    <description>Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction absorbed of oral PF-06700841</measure>
    <time_frame>hour 0 up to 144 hours post dose</time_frame>
    <description>Fraction absorbed in gut (Fa) following oral dose of PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolite identification_urine</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolite identification_feces</measure>
    <time_frame>hour 0 up to 312 hours post dose</time_frame>
    <description>metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Male Subjects</condition>
  <arm_group>
    <arm_group_label>2-period, fixed sequence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fixed sequence with 2 treatment period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral PF-06700841 containing 14C microtracer</intervention_name>
    <description>Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period</description>
    <arm_group_label>2-period, fixed sequence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral unlabeled PF-06700841</intervention_name>
    <description>60 mg unlabeled PF-06700841 oral dose in 2nd period</description>
    <arm_group_label>2-period, fixed sequence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV 14C-labeled PF-06700841</intervention_name>
    <description>30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period</description>
    <arm_group_label>2-period, fixed sequence</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).&#xD;
&#xD;
          -  Total 14C radioactivity measured in plasma exceeding 11 mBq/mL&#xD;
&#xD;
          -  History of tuberculosis or active or latent or inadequately treated infection,&#xD;
             positive QuantiFERON®-TB Gold test&#xD;
&#xD;
          -  Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine&#xD;
             cotinine test&#xD;
&#xD;
          -  Use of herbal supplements within 28 days prior to the first dose of study medication&#xD;
&#xD;
          -  Use of prescription or nonprescription drugs (including vitamins and dietary&#xD;
             supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first&#xD;
             dose of study medication. As an exception, acetaminophen may be used at doses of 1&#xD;
             g/day. Limited use of non-prescription medications that are not believed to affect&#xD;
             subject safety or the overall results of the study may be permitted on a case-by-case&#xD;
             basis following approval by Pfizer&#xD;
&#xD;
          -  Inability to have at least one bowel movement every 2 days on average eGFR of &lt;90&#xD;
             mL/mim/1.73 m2 based on MDRD equation&#xD;
&#xD;
          -  Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to&#xD;
             the first dose of investigational product, or expects to be vaccinated with these&#xD;
             vaccines during study treatment, or within the 6 weeks following the last dose of&#xD;
             investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PRA Health Sciences</name>
      <address>
        <city>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7931014&amp;StudyName=A+Phase+1%2C+Open-label%2C+Non-randomized%2C+2-period%2C+Fixed+Sequence+Study+To+Investigate+The+Absorption%2C+Distribution%2C+Metabolism+And+Excretion+Of+%5B14c-pf-06700841%5D+And+To+Assess+The+Absolute+Bioavailability+And+Fraction+Absorbed+Of+Pf-06700841+In+Healthy+Male+Subjects+Using+A+14c-microtracer+Approach</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PF-06700841</keyword>
  <keyword>mass balance</keyword>
  <keyword>metabolites</keyword>
  <keyword>absolute bioavailability</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PF-06700841</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770039
org study id: B7931014
secondary id: 2018-002403-34
nct id: NCT03770039
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: mass balance_urine
time frame: hour 0 up to 312 hours post dose
description: cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
measure: mass balance_feces
time frame: hour 0 up to 312 hours post dose
description: cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
measure: metabolite identification_plasma
time frame: hour 0 up to 312 hours post dose
description: metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841
measure: plasma Cmax for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
measure: plasma Tmax for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
measure: plasma AUClast for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841
measure: plasma AUCinf for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841
measure: Oral clearance for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841
measure: plasma half-life for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
measure: volume of distribution for total 14C radioactivity
time frame: hour 0 up to 312 hours post dose
description: apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841
measure: plasma Cmax for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
measure: plasma Tmax for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
measure: plasma AUClast for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: 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
measure: plasma AUCinf for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: 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
measure: Oral clearance for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
measure: plasma half-life for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
measure: volume of distribution for PF-06700841
time frame: hour 0 up to 96 hours post dose
description: apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
measure: plasma Cmax for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
measure: plasma Tmax for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
measure: plasma AUClast for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: 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
measure: plasma AUCinf for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841
measure: clearance for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
measure: plasma half-life for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
measure: volume of distribution for 14C-labeled PF-06700841
time frame: hour 0 up to 96 hours post dose
description: volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
measure: unchanged PF-06700841 recovered in urine
time frame: hour 0 up to 96 hours post dose
description: percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841
measure: renal clearance of PF-06700841
time frame: hour 0 up to 96 hours post dose
description: renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)
measure: Bioavailability of oral PF-06700841
time frame: hour 0 up to 96 hours post dose
description: Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841
measure: Fraction absorbed of oral PF-06700841
time frame: hour 0 up to 144 hours post dose
description: Fraction absorbed in gut (Fa) following oral dose of PF-06700841
measure: metabolite identification_urine
time frame: hour 0 up to 312 hours post dose
description: metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841
measure: metabolite identification_feces
time frame: hour 0 up to 312 hours post dose
description: metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841
arm group label: 2-period, fixed sequence
arm group type: Experimental
description: fixed sequence with 2 treatment period
intervention type: Drug
intervention name: Oral PF-06700841 containing 14C microtracer
description: Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
arm group label: 2-period, fixed sequence
intervention type: Drug
intervention name: Oral unlabeled PF-06700841
description: 60 mg unlabeled PF-06700841 oral dose in 2nd period
arm group label: 2-period, fixed sequence
intervention type: Drug
intervention name: IV 14C-labeled PF-06700841
description: 30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
arm group label: 2-period, fixed sequence
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
country: Netherlands
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7931014&StudyName=A+Phase+1%2C+Open-label%2C+Non-randomized%2C+2-period%2C+Fixed+Sequence+Study+To+Investigate+The+Absorption%2C+Distribution%2C+Metabolism+And+Excretion+Of+%5B14c-pf-06700841%5D+And+To+Assess+The+Absolute+Bioavailability+And+Fraction+Absorbed+Of+Pf-06700841+In+Healthy+Male+Subjects+Using+A+14c-microtracer+Approach
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: PF-06700841
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.