<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/NCT02231671</url>
  </required_header>
  <id_info>
    <org_study_id>ALS-008176-504</org_study_id>
    <nct_id>NCT02231671</nct_id>
  </id_info>
  <brief_title>A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176</brief_title>
  <official_title>A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of 14C-ALS-008176 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alios Biopharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alios Biopharma Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from&#xD;
      the body.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2014</start_date>
  <completion_date type="Actual">November 30, 2014</completion_date>
  <primary_completion_date type="Actual">September 30, 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Bioavailability</measure>
    <time_frame>Days 1-8</time_frame>
    <description>Determination of the absolute bioavailability of ALS-008112</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mass Balance</measure>
    <time_frame>Days 1 - 14</time_frame>
    <description>Mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>Days 1-14</time_frame>
    <description>Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the metabolic profile of [14C] - ALS-008176</measure>
    <time_frame>Days 1-14</time_frame>
    <description>To investigate the metabolic profile of [14C] - ALS-008176 in plasma, urine and faeces following oral administration in healthy male subjects (Part 2 only)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Respiratory Syncytial Virus Infections</condition>
  <arm_group>
    <arm_group_label>Part 1: Absolute Bioavilability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 1 of this study is an absolute bioavailability study where the IV (intravenous) microtracer dose of ALS-008112 is administered 15-30 minutes after the oral dose to determine the bioavailability of the oral dose compared to the IV dose. The maximum microtracer IV dose administered in Part 1 of this study will not exceed a single dose of 100 μg [14C]-ALS-008112 containing NMT (not more than) 37.0 kBq (1000 nCi) 14C. Based upon previous clinical observations, it is anticipated that the single oral dose and IV microdose to be utilised in Part 1 will provide acceptable PK data and will be safe and well tolerated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Mass Balance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2 of this study is an absorption, metabolism and excretion study, for which a single 375 mg [14C]-ALS-008176 (containing NMT 6.85 MBq (megabecquerel) (185 μCi) 14C) dose has been selected for evaluation based upon data from prior studies. Based upon previous clinical observations, it is anticipated that the dose to be utilised in Part 2 will provide acceptable PK data, will be safe and well tolerated and is within the therapeutic range.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALS-008176</intervention_name>
    <arm_group_label>Part 1: Absolute Bioavilability</arm_group_label>
    <arm_group_label>Part 2: Mass Balance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALS-008112</intervention_name>
    <arm_group_label>Part 1: Absolute Bioavilability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index 18.0 to 32.0 kg/m2 (inclusive) and a total body weight &gt;50 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Creatinine clearance as calculated by the Cockroft-Gault formula of less than 60&#xD;
             mL/min&#xD;
&#xD;
          -  Clinically significant abnormal biochemistry, haematology or urinalysis as judged by&#xD;
             the investigator or the sponsor medical monitor. Reticulocyte count, haemoglobin and&#xD;
             platelet counts must not be less than the lower limit of normal for the subject.&#xD;
&#xD;
          -  History of clinically significant cardiovascular, renal, hepatic, chronic respiratory,&#xD;
             GI, haematological, neurological, endocrinological, immunological, musculoskeletal&#xD;
             disease or any uncontrolled medical illness (eg active infection) or psychiatric&#xD;
             disorder, as judged by the investigator or medical monitor.&#xD;
&#xD;
          -  Clinically significant abnormal electrocardiogram (ECG) findings&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pui Leung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quotient Clinical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>October 27, 2017</last_update_submitted>
  <last_update_submitted_qc>October 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 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>Respiratory Syncytial Virus Infections</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/NCT02231671
org study id: ALS-008176-504
nct id: NCT02231671
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from
      the body.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Absolute Bioavailability
time frame: Days 1-8
description: Determination of the absolute bioavailability of ALS-008112
measure: Mass Balance
time frame: Days 1 - 14
description: Mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae)
measure: Safety
time frame: Days 1-14
description: Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.
measure: To investigate the metabolic profile of [14C] - ALS-008176
time frame: Days 1-14
description: To investigate the metabolic profile of [14C] - ALS-008176 in plasma, urine and faeces following oral administration in healthy male subjects (Part 2 only)
arm group label: Part 1: Absolute Bioavilability
arm group type: Experimental
description: Part 1 of this study is an absolute bioavailability study where the IV (intravenous) microtracer dose of ALS-008112 is administered 15-30 minutes after the oral dose to determine the bioavailability of the oral dose compared to the IV dose. The maximum microtracer IV dose administered in Part 1 of this study will not exceed a single dose of 100 μg [14C]-ALS-008112 containing NMT (not more than) 37.0 kBq (1000 nCi) 14C. Based upon previous clinical observations, it is anticipated that the single oral dose and IV microdose to be utilised in Part 1 will provide acceptable PK data and will be safe and well tolerated.
arm group label: Part 2: Mass Balance
arm group type: Experimental
description: Part 2 of this study is an absorption, metabolism and excretion study, for which a single 375 mg [14C]-ALS-008176 (containing NMT 6.85 MBq (megabecquerel) (185 μCi) 14C) dose has been selected for evaluation based upon data from prior studies. Based upon previous clinical observations, it is anticipated that the dose to be utilised in Part 2 will provide acceptable PK data, will be safe and well tolerated and is within the therapeutic range.
intervention type: Drug
intervention name: ALS-008176
arm group label: Part 1: Absolute Bioavilability
arm group label: Part 2: Mass Balance
intervention type: Drug
intervention name: ALS-008112
arm group label: Part 1: Absolute Bioavilability
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pui Leung
role: Principal Investigator
affiliation: Quotient Clinical
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Respiratory Syncytial Virus Infections