<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/NCT04495140</url>
  </required_header>
  <id_info>
    <org_study_id>C3421009</org_study_id>
    <secondary_id>2019-002584-10</secondary_id>
    <nct_id>NCT04495140</nct_id>
  </id_info>
  <brief_title>Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961</brief_title>
  <official_title>A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to&#xD;
      characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to&#xD;
      evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of&#xD;
      [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 15, 2020</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>Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1</measure>
    <time_frame>Baseline through approximately hour 312 (day 14). Period 1 is 14 days</time_frame>
    <description>Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolite profiling/identification in plasma, urine, and feces</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)</time_frame>
    <description>Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Maximum Observed Plasma Radioactivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Time to Reach Maximum Observed Plasma Radioactivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Area under the plasma radioactivity-time profile from time 0 to time of the last quantifiable concentration (Clast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Maximum Observed Plasma Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Time to Reach Maximum Observed Plasma Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961</measure>
    <time_frame>0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>where MRT is the Mean Residence Time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961</measure>
    <time_frame>0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961</measure>
    <time_frame>0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute oral bioavailability (F)</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of dose absorbed following single oral administration of [14C]PF-06882961</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr</time_frame>
    <description>Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days</time_frame>
    <description>adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961</measure>
    <time_frame>00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr</time_frame>
    <description>Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with safety laboratory test results above/below certain threshold</measure>
    <time_frame>baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)</time_frame>
    <description>lab tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with ECG measurements above/below certain threshold</measure>
    <time_frame>baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)</time_frame>
    <description>ECGs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with vital measurements above/below certain threshold</measure>
    <time_frame>baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)</time_frame>
    <description>vitals</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Oral [14C]PF-06882961, 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, a single oral dose of [14C]PF-06882961, 50 mg will be administered as a liquid formulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961, 100 ug, will be administered via intravenous infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]PF-06882961, 50 mg</intervention_name>
    <description>A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.</description>
    <arm_group_label>Oral [14C]PF-06882961, 50 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06882961, 50 mg and [14C]PF-06882961, 100 ug</intervention_name>
    <description>A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.</description>
    <arm_group_label>Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male participants between 18 to 54 years of age&#xD;
&#xD;
          -  Healthy and capable of signing informed consent document&#xD;
&#xD;
          -  Willing to comply to all scheduled visits, lab tests, lifestyle considerations and&#xD;
             study procedures&#xD;
&#xD;
          -  Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute or chronic medical or psychiatric condition including recent (within the past&#xD;
             year)&#xD;
&#xD;
          -  Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements&#xD;
&#xD;
          -  Use of prescription or non-prescription drugs and dietary and herbal supplements&#xD;
             within 14 days prior to the first dose of investigational product.&#xD;
&#xD;
          -  Previous administration with an investigational drug within 60 days (or as determined&#xD;
             by the local requirement) preceding the first dose of investigational product used in&#xD;
             this study.&#xD;
&#xD;
          -  Known prior participation in a trial involving PF-06882961 or known intolerance to a&#xD;
             GLP-1R agonist.&#xD;
&#xD;
          -  A positive urine drug test on screening or Day -1.&#xD;
&#xD;
          -  Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic),&#xD;
             following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm&#xD;
             Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP&#xD;
             values should be used to determine the participant's eligibility.&#xD;
&#xD;
          -  Participants with abnormalities in clinical laboratory tests including ECGs, vital&#xD;
             signs, liver function tests, myocardial infarction&#xD;
&#xD;
          -  Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
             (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.&#xD;
&#xD;
          -  History of alcohol or tobacco abuse or binge drinking and/or any other illicit drug&#xD;
             use or dependence within past 6 months.&#xD;
&#xD;
          -  Subjects whose occupation requires exposure to radiation or monitoring of radiation&#xD;
             exposure.&#xD;
&#xD;
          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 60 days prior to dosing.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin&#xD;
             is planned to flush intravenous catheters.&#xD;
&#xD;
          -  Investigator site staff members directly involved in the conduct of the study and&#xD;
             their family members, site staff members otherwise supervised by the investigator, or&#xD;
             Pfizer employees, including their family members, directly involved in the conduct of&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 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://pmiform.com/clinical-trial-info-request?StudyID=C3421009</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bioavailability</keyword>
  <keyword>excretion</keyword>
  <keyword>metabolism</keyword>
  <keyword>absorption</keyword>
  <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/NCT04495140
org study id: C3421009
secondary id: 2019-002584-10
nct id: NCT04495140
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to
      characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to
      evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of
      [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1
time frame: Baseline through approximately hour 312 (day 14). Period 1 is 14 days
description: Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
measure: Metabolite profiling/identification in plasma, urine, and feces
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)
description: Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces.
measure: Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Maximum Observed Plasma Radioactivity
measure: Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Time to Reach Maximum Observed Plasma Radioactivity
measure: Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Area under the plasma radioactivity-time profile from time 0 to time of the last quantifiable concentration (Clast)
measure: Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
measure: Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961
time frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
measure: Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Maximum Observed Plasma Concentration
measure: Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Time to Reach Maximum Observed Plasma Concentration
measure: Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast)
measure: Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
measure: Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961
time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
description: where MRT is the Mean Residence Time
measure: Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961
time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
description: Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body.
measure: Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961
time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
measure: Absolute oral bioavailability (F)
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961
measure: Fraction of dose absorbed following single oral administration of [14C]PF-06882961
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr
description: Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration
measure: Number of participants with adverse events
time frame: Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days
description: adverse events
measure: Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961
time frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
description: Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
measure: Number of participants with safety laboratory test results above/below certain threshold
time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
description: lab tests
measure: Number of participants with ECG measurements above/below certain threshold
time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
description: ECGs
measure: Number of participants with vital measurements above/below certain threshold
time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
description: vitals
arm group label: Oral [14C]PF-06882961, 50 mg
arm group type: Experimental
description: In this arm, a single oral dose of [14C]PF-06882961, 50 mg will be administered as a liquid formulation.
arm group label: Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug
arm group type: Experimental
description: In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961, 100 ug, will be administered via intravenous infusion.
intervention type: Drug
intervention name: [14C]PF-06882961, 50 mg
description: A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
arm group label: Oral [14C]PF-06882961, 50 mg
intervention type: Drug
intervention name: PF-06882961, 50 mg and [14C]PF-06882961, 100 ug
description: A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.
arm group label: Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
country: Netherlands
url: https://pmiform.com/clinical-trial-info-request?StudyID=C3421009
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
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.