<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/NCT01665924</url>
  </required_header>
  <id_info>
    <org_study_id>GLPG0634-CL-104</org_study_id>
    <nct_id>NCT01665924</nct_id>
  </id_info>
  <brief_title>Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects</brief_title>
  <official_title>Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galapagos NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galapagos NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the amount of compound present in the blood&#xD;
      (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy&#xD;
      subjects.&#xD;
&#xD;
      During the course of the study, the effect of aging on the pharmacokinetics as well as the&#xD;
      effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics)&#xD;
      will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy&#xD;
      subjects will be characterized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634</measure>
    <time_frame>From predose (before first study drug administration) up to 72 hours post last study drug administration</time_frame>
    <description>To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634</measure>
    <time_frame>From predose (before first study drug administration) up to 24 hours post last study drug administration</time_frame>
    <description>To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - after multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>From screening up to 10 days after the last study drug administration</time_frame>
    <description>To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of the number of adverse events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vital signs as measured by heart rate, blood pressure and body temperature</measure>
    <time_frame>From screening up to 10 days after the last study drug administration</time_frame>
    <description>To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 12-lead ECG measures</measure>
    <time_frame>From screening up to 10 days after the last study drug administration</time_frame>
    <description>To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in 12-ECG measures reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical exam measures</measure>
    <time_frame>From screening up to 10 days after the last study drug administration</time_frame>
    <description>To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in physical examination reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood safety lab parameters</measure>
    <time_frame>From screening up to 10 days after the last study drug administration</time_frame>
    <description>To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in blood safety lab parameters assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in urine safety lab parameters</measure>
    <time_frame>From screening up to 10 days after the last study drug administration</time_frame>
    <description>To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in urine safety lab parameters assessed</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>40-50 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>65-74 years old</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>75 years and older</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLPG0634 100mg capsule once a day for 10 days</intervention_name>
    <arm_group_label>40-50 years old</arm_group_label>
    <arm_group_label>65-74 years old</arm_group_label>
    <arm_group_label>75 years and older</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female, age 40 years and older&#xD;
&#xD;
          -  BMI between 18-30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that might interfere with the procedures or tests in this study&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Vanhoutte, MD</last_name>
    <role>Study Director</role>
    <affiliation>Galapagos NV</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Magdalena Petkova, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SGS LSS Clinical Pharmacology Unit Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SGS LSS Clinical Pharmacology Unit Antwerp</name>
      <address>
        <city>Antwerp</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>March 26, 2013</last_update_submitted>
  <last_update_submitted_qc>March 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 28, 2013</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/NCT01665924
org study id: GLPG0634-CL-104
nct id: NCT01665924
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the amount of compound present in the blood
      (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy
      subjects.

      During the course of the study, the effect of aging on the pharmacokinetics as well as the
      effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics)
      will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy
      subjects will be characterized.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634
time frame: From predose (before first study drug administration) up to 72 hours post last study drug administration
description: To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging
measure: The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634
time frame: From predose (before first study drug administration) up to 24 hours post last study drug administration
description: To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - after multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging
measure: Number of adverse events
time frame: From screening up to 10 days after the last study drug administration
description: To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of the number of adverse events reported
measure: Changes in vital signs as measured by heart rate, blood pressure and body temperature
time frame: From screening up to 10 days after the last study drug administration
description: To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported
measure: Changes in 12-lead ECG measures
time frame: From screening up to 10 days after the last study drug administration
description: To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in 12-ECG measures reported
measure: Changes in physical exam measures
time frame: From screening up to 10 days after the last study drug administration
description: To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in physical examination reported
measure: Changes in blood safety lab parameters
time frame: From screening up to 10 days after the last study drug administration
description: To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in blood safety lab parameters assessed
measure: Changes in urine safety lab parameters
time frame: From screening up to 10 days after the last study drug administration
description: To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in urine safety lab parameters assessed
arm group label: 40-50 years old
arm group type: Experimental
description: GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old
arm group label: 65-74 years old
arm group type: Experimental
description: GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old
arm group label: 75 years and older
arm group type: Experimental
description: GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older
intervention type: Drug
intervention name: GLPG0634 100mg capsule once a day for 10 days
arm group label: 40-50 years old
arm group label: 65-74 years old
arm group label: 75 years and older
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frédéric Vanhoutte, MD
role: Study Director
affiliation: Galapagos NV
last name: Magdalena Petkova, MD
role: Principal Investigator
affiliation: SGS LSS Clinical Pharmacology Unit Antwerp
facility: 
country: Belgium
responsible party type: Sponsor