<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/NCT01695876</url>
  </required_header>
  <id_info>
    <org_study_id>20110246</org_study_id>
    <secondary_id>Inflammation</secondary_id>
    <nct_id>NCT01695876</nct_id>
  </id_info>
  <brief_title>A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <brief_summary>
    <textblock>
      Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy&#xD;
      subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability</measure>
    <time_frame>up to 35 days</time_frame>
    <description>Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics</measure>
    <time_frame>up to 35 days</time_frame>
    <description>Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Food on AMG 357</measure>
    <time_frame>up to 11 days</time_frame>
    <description>To assess the effect of food on the PK parameters of AMG 357</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Inflammatory Disease</condition>
  <arm_group>
    <arm_group_label>AMG 357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AMG 357 is a small molecule for treatment of inflammatory disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo to AMG 357 containing no active drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 357</intervention_name>
    <description>Oral administration available in varying dose strength.</description>
    <arm_group_label>AMG 357</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo to AMG 357 containing no active drug</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Adult subjects between 25 and 55 years old&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 32 kg/m2&#xD;
&#xD;
          -  Normal or clinically acceptable physical examination, clinical laboratory values, and&#xD;
             ECG&#xD;
&#xD;
          -  Additional inclusion criteria apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history or evidence of a clinically significant disorder, condition or disease&#xD;
             that would pose a risk to subject safety.&#xD;
&#xD;
          -  Additional exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grafton, Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>March 2, 2015</last_update_submitted>
  <last_update_submitted_qc>March 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01695876
org study id: 20110246
secondary id: Inflammation
nct id: NCT01695876
lead sponsor: 
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy
      subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety and Tolerability
time frame: up to 35 days
description: Examine the number of adverse events per subject, and subject incidence of clinically significant changes in physical examinations, vital signs, laboratory safety tests and electrocardiograms, after single and multiple dose administration of AMG 357 in healthy subjects.
measure: Pharmacodynamics
time frame: up to 35 days
description: Measure the area under the plasma concentration curve versus time of AMG 357 after single and multiple dose administration in healthy subjects
measure: Effect of Food on AMG 357
time frame: up to 11 days
description: To assess the effect of food on the PK parameters of AMG 357
arm group label: AMG 357
arm group type: Experimental
description: AMG 357 is a small molecule for treatment of inflammatory disease
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo to AMG 357 containing no active drug
intervention type: Drug
intervention name: AMG 357
description: Oral administration available in varying dose strength.
arm group label: AMG 357
intervention type: Drug
intervention name: Placebo
description: Matching placebo to AMG 357 containing no active drug
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
country: New Zealand
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor