<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/NCT03787186</url>
  </required_header>
  <id_info>
    <org_study_id>GLPG1690-CL-107</org_study_id>
    <nct_id>NCT03787186</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Given by Mouth and Into a Vein as an Injection</brief_title>
  <official_title>A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1690 in Healthy Male Subjects Following Single Intravenous GLPG1690 Microtracer and Oral [14C]-GLPG1690 Administrations.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The sponsor wants to investigate how well the test medicine is taken up by the body when&#xD;
      given orally (by mouth) as a tablet or capsule and as a solution for infusion (into a vein).&#xD;
      The capsule and the solution will be radiolabelled. 'Radiolabelled' means that the test&#xD;
      medicine has a radioactive component which helps us to track where the test medicine is in&#xD;
      the body.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)</measure>
    <time_frame>From Day 1 pre-dose up to Day 10</time_frame>
    <description>To assess the mass balance using [14C]-GLPG1690.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).</measure>
    <time_frame>From Day 1 pre-dose up to Day 10</time_frame>
    <description>To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).</measure>
    <time_frame>From Day 1 pre-dose up to Day 10</time_frame>
    <description>To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) of total radioactivity (Part 2).</measure>
    <time_frame>From Day 1 pre-dose up to Day 10</time_frame>
    <description>To assess the PK of GLPG1690 and its main metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).</measure>
    <time_frame>From Day 1 pre-dose up to Day 10</time_frame>
    <description>To assess the PK of GLPG1690 and its main metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).</measure>
    <time_frame>From Day 1 pre-dose up to Day 7</time_frame>
    <description>To better characterize the elimination pathways and metabolite profile of GLPG1690</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).</measure>
    <time_frame>From Day 1 pre-dose up to Day 4</time_frame>
    <description>To assess the PK of GLPG1690 and its main metabolites in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).</measure>
    <time_frame>From Day 1 pre-dose up to Day 4</time_frame>
    <description>To assess the PK of GLPG1690 and its main metabolites in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IV Area under the plasma concentration-time curve (AUC) of [14C]-GLPG1690 microtracer (MT) (Part 1).</measure>
    <time_frame>From Day 1 pre-dose up to Day 4</time_frame>
    <description>To assess the PK of GLPG1690 and its main metabolites in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IV Area under the plasma concentration-time curve (AUC) of total radioactivity(Part 1).</measure>
    <time_frame>From Day 1 pre-dose up to Day 4</time_frame>
    <description>To assess the PK of GLPG1690 and its main metabolites in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of GLPG1690, assessed by the number of subjects with adverse events (AEs) (Part 1 and Part 2).</measure>
    <time_frame>From screening through study completion, an average of 2 months</time_frame>
    <description>To evaluate the safety and tolerability of GLPG1690 (in Part 1 and Part 2).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>GLPG1690 oral and IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GLPG1690 film-coated tablets followed by [14C]-GLPG1690 solution for infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>[14C]-GLPG1690 capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[14C]-GLPG1690 capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLPG1690 film-coated tablets</intervention_name>
    <description>a single oral dose of GLPG1690</description>
    <arm_group_label>GLPG1690 oral and IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-GLPG1690 solution for infusion</intervention_name>
    <description>a 15-minute IV infusion [14C]-GLPG1690</description>
    <arm_group_label>GLPG1690 oral and IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-GLPG1690 capsules</intervention_name>
    <description>single oral dose of [14C]-GLPG1690</description>
    <arm_group_label>[14C]-GLPG1690 capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to comply with the clinical study protocol (CSP) requirements and&#xD;
             sign the informed consent form (ICF) as approved by the Independent Ethics Committee&#xD;
             (IEC), before any screening evaluations.&#xD;
&#xD;
          -  Male subjects between 30 to 64 years of age (extremes included), on the date of&#xD;
             signing the ICF.&#xD;
&#xD;
          -  A body mass index between 18 to 32 kg/m2 (extremes included).&#xD;
&#xD;
          -  Judged to be in good health by the investigator based upon the results of a medical&#xD;
             history, physical examination, vital signs, 12-lead ECG, and fasting clinical&#xD;
             laboratory safety tests, and not having had any clinically significant illness in the&#xD;
             3 months before first investigational medicinal product (IMP) administration.&#xD;
&#xD;
          -  Having a regular and (at least) daily defecation pattern.&#xD;
&#xD;
          -  Able and willing to comply with restrictions on prior and concomitant medication as&#xD;
             described in the protocol.&#xD;
&#xD;
          -  Nonsmoker, defined as an individual who has abstained from smoking (or the use of&#xD;
             e-cigarettes or nicotine containing products) from at least 2 months before screening.&#xD;
             Having a breath carbon monoxide reading of ≤10 parts per million.&#xD;
&#xD;
          -  Negative urine drug screen (e.g. amphetamines, barbiturates, benzodiazepines,&#xD;
             cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol breath&#xD;
             test.&#xD;
&#xD;
          -  Male subjects with female partners of childbearing potential willing to comply with&#xD;
             the contraceptive methods described in the protocol from the time of the first IMP&#xD;
             administration, during the clinical study, and for at least 90 days after the last IMP&#xD;
             administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to IMP ingredients or history of a significant allergic&#xD;
             reaction to IMP ingredients as determined by the investigator, such as anaphylaxis&#xD;
             requiring hospitalization, and/or known sensitivity to IMP or the excipients (e.g.&#xD;
             lactose). Hayfever is allowed unless active.&#xD;
&#xD;
          -  Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus&#xD;
             (HCV) antibody, or history of hepatitis from any cause with the exception of a history&#xD;
             of hepatitis A infection at least 12 weeks before first IMP administration.&#xD;
&#xD;
          -  History of or a current immunosuppressive condition (e.g. human immunodeficiency virus&#xD;
             [HIV] infection).&#xD;
&#xD;
          -  Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80&#xD;
             mL/min, using the Cockcroft-Gault formula), or other conditions known to interfere&#xD;
             with the absorption, distribution, metabolism, and excretion (ADME) properties of&#xD;
             drugs. Subjects with documented Gilbert's syndrome are eligible for inclusion in the&#xD;
             study.&#xD;
&#xD;
          -  History of malignancy within the past 5 years (except for basal cell carcinoma of the&#xD;
             skin that has been treated and with no evidence of recurrence).&#xD;
&#xD;
          -  Hemoglobin level below the lower limit of normal (LLN; 13.0 g/dL). Retesting is&#xD;
             allowed once.&#xD;
&#xD;
          -  Significant blood loss (including blood donation [&gt;450 mL]) or transfusion of any&#xD;
             blood product within 12 weeks before screening.&#xD;
&#xD;
          -  Active drug abuse (per investigator judgment) or alcohol abuse (more than three&#xD;
             glasses of wine, beer, or equivalent/day) within 3 months before first IMP&#xD;
             administration.&#xD;
&#xD;
          -  Concurrent participation or participation in a drug, drug/device or biologic&#xD;
             investigational research study within 12 weeks or 5 half-lives of the drug, whichever&#xD;
             is longer, before first IMP administration.&#xD;
&#xD;
          -  Radiation exposure, including that from the present study, excluding background&#xD;
             radiation but including diagnostic Xrays and other medical exposures, exceeding 5&#xD;
             millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No&#xD;
             occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999,&#xD;
             can participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Brearley, BM. MRCP</last_name>
    <role>Study Director</role>
    <affiliation>Galapagos NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Sciences Limited</name>
      <address>
        <city>Ruddington</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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/NCT03787186
org study id: GLPG1690-CL-107
nct id: NCT03787186
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The sponsor wants to investigate how well the test medicine is taken up by the body when
      given orally (by mouth) as a tablet or capsule and as a solution for infusion (into a vein).
      The capsule and the solution will be radiolabelled. 'Radiolabelled' means that the test
      medicine has a radioactive component which helps us to track where the test medicine is in
      the body.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)
time frame: From Day 1 pre-dose up to Day 10
description: To assess the mass balance using [14C]-GLPG1690.
measure: Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).
time frame: From Day 1 pre-dose up to Day 10
description: To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma
measure: Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).
time frame: From Day 1 pre-dose up to Day 10
description: To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma
measure: Area under the plasma concentration-time curve (AUC) of total radioactivity (Part 2).
time frame: From Day 1 pre-dose up to Day 10
description: To assess the PK of GLPG1690 and its main metabolites in plasma
measure: Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).
time frame: From Day 1 pre-dose up to Day 10
description: To assess the PK of GLPG1690 and its main metabolites in plasma
measure: Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).
time frame: From Day 1 pre-dose up to Day 7
description: To better characterize the elimination pathways and metabolite profile of GLPG1690
measure: Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).
time frame: From Day 1 pre-dose up to Day 4
description: To assess the PK of GLPG1690 and its main metabolites in plasma.
measure: Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).
time frame: From Day 1 pre-dose up to Day 4
description: To assess the PK of GLPG1690 and its main metabolites in plasma.
measure: IV Area under the plasma concentration-time curve (AUC) of [14C]-GLPG1690 microtracer (MT) (Part 1).
time frame: From Day 1 pre-dose up to Day 4
description: To assess the PK of GLPG1690 and its main metabolites in plasma.
measure: IV Area under the plasma concentration-time curve (AUC) of total radioactivity(Part 1).
time frame: From Day 1 pre-dose up to Day 4
description: To assess the PK of GLPG1690 and its main metabolites in plasma.
measure: Safety and tolerability of GLPG1690, assessed by the number of subjects with adverse events (AEs) (Part 1 and Part 2).
time frame: From screening through study completion, an average of 2 months
description: To evaluate the safety and tolerability of GLPG1690 (in Part 1 and Part 2).
arm group label: GLPG1690 oral and IV
arm group type: Experimental
description: GLPG1690 film-coated tablets followed by [14C]-GLPG1690 solution for infusion
arm group label: [14C]-GLPG1690 capsules
arm group type: Experimental
description: [14C]-GLPG1690 capsules
intervention type: Drug
intervention name: GLPG1690 film-coated tablets
description: a single oral dose of GLPG1690
arm group label: GLPG1690 oral and IV
intervention type: Drug
intervention name: [14C]-GLPG1690 solution for infusion
description: a 15-minute IV infusion [14C]-GLPG1690
arm group label: GLPG1690 oral and IV
intervention type: Drug
intervention name: [14C]-GLPG1690 capsules
description: single oral dose of [14C]-GLPG1690
arm group label: [14C]-GLPG1690 capsules
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Brearley, BM. MRCP
role: Study Director
affiliation: Galapagos NV
facility: 
country: United Kingdom
responsible party type: Sponsor