<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/NCT01721980</url>
  </required_header>
  <id_info>
    <org_study_id>GLPG0974-CL-102</org_study_id>
    <nct_id>NCT01721980</nct_id>
  </id_info>
  <brief_title>Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects</brief_title>
  <official_title>Double-blind, Randomized, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0974 in Healthy Male 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 this study is to evaluate the safety and tolerability after multiple ascending&#xD;
      oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.&#xD;
&#xD;
      Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and&#xD;
      urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related&#xD;
      parameters in the blood and stool samples (pharmacodynamics) will be characterized compared&#xD;
      to placebo.&#xD;
&#xD;
      Also, the effect of the compound on glucose tolerance will be explored as well as the&#xD;
      potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>Between screening and 7-10 days after the last dose</time_frame>
    <description>To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of GLPG0974 in plasma and urine over time after multiple oral dose</measure>
    <time_frame>Between Day 1 predose and Day 14</time_frame>
    <description>To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974</measure>
    <time_frame>Day 1 and Day 13, predose until 24h post dose</time_frame>
    <description>To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ratio of 6b-hydroxycortisol/cortisol in urine</measure>
    <time_frame>Predose and postdose on Day 1 and Day 13 for 24h</time_frame>
    <description>Potential of CYP3A4 induction by repeated dosing with GLPG0974 will be assessed by means of the ratio of 6b-hydroxycortisol/cortisol in urine</description>
  </other_outcome>
  <other_outcome>
    <measure>Levels of faecal calprotectin in stool</measure>
    <time_frame>Prior to first dosing and postdose (between Day 12 and 15)</time_frame>
    <description>Concentrations of faecal calprotectin will be measured as a pharmacodynamic marker in a single stool sample predose and postdose</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucose and insulin concentrations after glucose loading</measure>
    <time_frame>Day -1 (predose) and Day 14 (postdose)</time_frame>
    <description>Oral glucose tolerance test by means of measuring concentrations of glucose and insulin after glucose loading, once predosing and once postdosing of GLPG0974</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>50 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLPG0974</intervention_name>
    <arm_group_label>100 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_label>200 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_label>400 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_label>50 mg GLPG0974 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>100 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_label>200 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_label>400 mg GLPG0974 or placebo</arm_group_label>
    <arm_group_label>50 mg GLPG0974 or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male, age 18-50 years&#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>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>Frédéric Vanhoutte, MD</last_name>
    <role>Study Director</role>
    <affiliation>Galapagos NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SGS LSS Clinical Pharmacology Unit Antwerp</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>February 9, 2013</last_update_submitted>
  <last_update_submitted_qc>February 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 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/NCT01721980
org study id: GLPG0974-CL-102
nct id: NCT01721980
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and tolerability after multiple ascending
      oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

      Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and
      urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related
      parameters in the blood and stool samples (pharmacodynamics) will be characterized compared
      to placebo.

      Also, the effect of the compound on glucose tolerance will be explored as well as the
      potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and tolerability
time frame: Between screening and 7-10 days after the last dose
description: To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
measure: The amount of GLPG0974 in plasma and urine over time after multiple oral dose
time frame: Between Day 1 predose and Day 14
description: To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects
measure: Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974
time frame: Day 1 and Day 13, predose until 24h post dose
description: To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects
measure: Ratio of 6b-hydroxycortisol/cortisol in urine
time frame: Predose and postdose on Day 1 and Day 13 for 24h
description: Potential of CYP3A4 induction by repeated dosing with GLPG0974 will be assessed by means of the ratio of 6b-hydroxycortisol/cortisol in urine
measure: Levels of faecal calprotectin in stool
time frame: Prior to first dosing and postdose (between Day 12 and 15)
description: Concentrations of faecal calprotectin will be measured as a pharmacodynamic marker in a single stool sample predose and postdose
measure: Glucose and insulin concentrations after glucose loading
time frame: Day -1 (predose) and Day 14 (postdose)
description: Oral glucose tolerance test by means of measuring concentrations of glucose and insulin after glucose loading, once predosing and once postdosing of GLPG0974
arm group label: 50 mg GLPG0974 or placebo
arm group type: Other
description: 50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
arm group label: 100 mg GLPG0974 or placebo
arm group type: Other
description: 100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
arm group label: 200 mg GLPG0974 or placebo
arm group type: Other
description: 200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
arm group label: 400 mg GLPG0974 or placebo
arm group type: Other
description: 400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
intervention type: Drug
intervention name: GLPG0974
arm group label: 100 mg GLPG0974 or placebo
arm group label: 200 mg GLPG0974 or placebo
arm group label: 400 mg GLPG0974 or placebo
arm group label: 50 mg GLPG0974 or placebo
intervention type: Drug
intervention name: Placebo
arm group label: 100 mg GLPG0974 or placebo
arm group label: 200 mg GLPG0974 or placebo
arm group label: 400 mg GLPG0974 or placebo
arm group label: 50 mg GLPG0974 or placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frédéric Vanhoutte, MD
role: Study Director
affiliation: Galapagos NV
facility: 
country: Belgium
responsible party type: Sponsor