<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/NCT02218294</url>
  </required_header>
  <id_info>
    <org_study_id>BCX4161-103</org_study_id>
    <nct_id>NCT02218294</nct_id>
  </id_info>
  <brief_title>Study to Determine How BCX4161 is Metabolized and Eliminated by the Body</brief_title>
  <official_title>A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioCryst Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioCryst Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by&#xD;
      mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made&#xD;
      by the body, the chemical composition of these metabolites and their profile over time in&#xD;
      blood and urine will be determined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces</measure>
    <time_frame>Determined from samples drawn up to 14 days post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine</measure>
    <time_frame>Determined from samples drawn up to 4 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161</measure>
    <time_frame>Data generated from samples drawn up to 7 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161</measure>
    <time_frame>Data generated from samples drawn up to 7 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations</measure>
    <time_frame>Over the duration of the study, approximately 6 weeks from screening through follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Hereditary Angioedema</condition>
  <arm_group>
    <arm_group_label>[14C] BCX4161</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCX4161</intervention_name>
    <arm_group_label>[14C] BCX4161</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy males&#xD;
&#xD;
          2. Age 30 to 65 years of age (inclusive)&#xD;
&#xD;
          3. Body mass index of 18.0 to 32.0 kg/m2&#xD;
&#xD;
          4. Must be willing and able to communicate and participate in the whole study&#xD;
&#xD;
          5. Must provide written informed consent&#xD;
&#xD;
          6. A history of regular bowel movements&#xD;
&#xD;
          7. Must agree to use an adequate method of contraception&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical research study within the previous 3 months&#xD;
&#xD;
          2. Current or history of any drug or alcohol abuse in the past 2 years or positive drugs&#xD;
             of abuse screen&#xD;
&#xD;
          3. Current smokers&#xD;
&#xD;
          4. Radiation exposure, including that from the present study, exceeding 5 mSv in the last&#xD;
             12 months or 10 mSv in the last 5 years&#xD;
&#xD;
          5. Clinically significant medical history, current medical or psychiatric condition, ECG&#xD;
             finding, or laboratory/urinalysis abnormality&#xD;
&#xD;
          6. Activated partial thromboplastin time or PT outside of normal laboratory limits&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Collier, MBChB, FFPM, Dip Stats (OU)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quotient Clinical Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical Ltd</name>
      <address>
        <city>Ruddington</city>
        <state>Nottingham</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 27, 2014</last_update_submitted>
  <last_update_submitted_qc>October 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BCX4161</keyword>
  <keyword>BioCryst</keyword>
  <keyword>hereditary angioedema</keyword>
  <keyword>mass balance</keyword>
  <keyword>kallikrein inhibitor</keyword>
  <keyword>ADME</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angioedema</mesh_term>
    <mesh_term>Angioedemas, Hereditary</mesh_term>
  </condition_browse>
  <!-- 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/NCT02218294
org study id: BCX4161-103
nct id: NCT02218294
lead sponsor: 
has dmc: No
The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by
      mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made
      by the body, the chemical composition of these metabolites and their profile over time in
      blood and urine will be determined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces
time frame: Determined from samples drawn up to 14 days post-dose
measure: Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine
time frame: Determined from samples drawn up to 4 days post-dose
measure: Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161
time frame: Data generated from samples drawn up to 7 days post-dose
measure: Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161
time frame: Data generated from samples drawn up to 7 days post-dose
measure: Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations
time frame: Over the duration of the study, approximately 6 weeks from screening through follow-up
arm group label: [14C] BCX4161
arm group type: Experimental
description: Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161
intervention type: Drug
intervention name: BCX4161
arm group label: [14C] BCX4161
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne Collier, MBChB, FFPM, Dip Stats (OU)
role: Principal Investigator
affiliation: Quotient Clinical Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Angioedema
mesh term: Angioedemas, Hereditary