<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/NCT03014375</url>
  </required_header>
  <id_info>
    <org_study_id>BIA-5453-103</org_study_id>
    <nct_id>NCT03014375</nct_id>
  </id_info>
  <brief_title>Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites</brief_title>
  <official_title>An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 5-453 and Metabolites Following a Single-dose Oral Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bial - Portela C S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bial - Portela C S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to:&#xD;
&#xD;
      To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and&#xD;
      faeces&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements&#xD;
      (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and&#xD;
      after the study, adverse events will be monitored throughout the study.&#xD;
&#xD;
      Subjects should be hospitalized the day before the administration until 264 hours thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">October 2008</completion_date>
  <primary_completion_date type="Actual">October 2008</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>urinary excretion of BIA 5-453 associated radioactivity</measure>
    <time_frame>pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.</time_frame>
    <description>following a single 600 mg oral dose labeled with 98 μCi of [14C]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>faecal excretion of BIA 5-453 associated radioactivity</measure>
    <time_frame>following a single 600 mg oral dose labeled with 98 μCi of [14C]</time_frame>
    <description>baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>amount of BIA 5-453 associated radioactivity present in the expired air</measure>
    <time_frame>baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose</time_frame>
    <description>following a single 600 mg oral dose labeled with 98 μCi of [14C]</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Hypertension</condition>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Etamicastat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIA-5-453</intervention_name>
    <description>Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).</description>
    <arm_group_label>Etamicastat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Caucasian male subjects, 40-55 years of age.&#xD;
&#xD;
          -  Sitting blood pressure and pulse rate within a clinically acceptable range for the&#xD;
             purposes of the study, i.e.: BP: 100 160 mmHg systolic, 50 95 mmHg diastolic and pulse&#xD;
             rate: 50 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in&#xD;
             a sitting position.&#xD;
&#xD;
          -  Subject body mass index must be between 18 and 28 kg/m2&#xD;
&#xD;
          -  Normal 12-lead ECG&#xD;
&#xD;
          -  Ability to communicate well with the investigator and comply with the requirements of&#xD;
             the entire study.&#xD;
&#xD;
          -  The subject has given his written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious adverse reactions or hypersensitivity to any drug.&#xD;
&#xD;
          -  Presence or history of allergies requiring acute or chronic treatment (except seasonal&#xD;
             allergic rhinitis).&#xD;
&#xD;
          -  History of alcohol or drug abuse in the last 5 years.&#xD;
&#xD;
          -  Abnormal physical findings of clinical significance at the screening examination or&#xD;
             baseline which would interfere with the objectives of the study.&#xD;
&#xD;
          -  Need of any prescription medication within 14 days prior to the administration of the&#xD;
             drug and/or nonprescription medication within 7 days prior to the administration of&#xD;
             the drug.&#xD;
&#xD;
          -  Participation in other clinical trials during the previous month in which an&#xD;
             investigational drug or a commercially available drug was tested.&#xD;
&#xD;
          -  Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a&#xD;
             donor.&#xD;
&#xD;
          -  Existence of any surgical or medical condition which might interfere with the&#xD;
             absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or&#xD;
             hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of&#xD;
             pronounced constipation or diarrhoea or conditions associated with total or partial&#xD;
             obstruction of the urinary tract.&#xD;
&#xD;
          -  Symptoms of a significant somatic or mental illness in the 4 week period preceding&#xD;
             drug administration.&#xD;
&#xD;
          -  History of hepatitis B and / or C and / or positive serology results which indicate&#xD;
             the presence of hepatitis B and / or C.&#xD;
&#xD;
          -  Positive results from the HIV serology.&#xD;
&#xD;
          -  Clinically significant abnormal laboratory values (as determined by the Principal&#xD;
             Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT)&#xD;
             values must be within the normal range.&#xD;
&#xD;
          -  Positive results of the drug screening.&#xD;
&#xD;
          -  Known hypersensitivity to BIA 5-453.&#xD;
&#xD;
          -  Heavy smokers, i.e., more than 10 cigarettes per day&#xD;
&#xD;
          -  Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray&#xD;
             investigation)&#xD;
&#xD;
          -  Subject who had more than 4 flights (with more than 2 hours flight time) within the&#xD;
             last year prior to the administration of the drug&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Swiss Pharma Contract Ltd.</name>
      <address>
        <city>Allschwil</city>
        <zip>CH-4123</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03014375
org study id: BIA-5453-103
nct id: NCT03014375
lead sponsor: 
has dmc: No
The purpose of this study is to:

      To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and
      faeces
Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements
      (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and
      after the study, adverse events will be monitored throughout the study.

      Subjects should be hospitalized the day before the administration until 264 hours thereafter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: urinary excretion of BIA 5-453 associated radioactivity
time frame: pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.
description: following a single 600 mg oral dose labeled with 98 μCi of [14C]
measure: faecal excretion of BIA 5-453 associated radioactivity
time frame: following a single 600 mg oral dose labeled with 98 μCi of [14C]
description: baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.
measure: amount of BIA 5-453 associated radioactivity present in the expired air
time frame: baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose
description: following a single 600 mg oral dose labeled with 98 μCi of [14C]
arm group label: Etamicastat
arm group type: Experimental
description: Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules
intervention type: Drug
intervention name: BIA-5-453
description: Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).
arm group label: Etamicastat
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided