<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/NCT03799978</url>
  </required_header>
  <id_info>
    <org_study_id>ID-078-113</org_study_id>
    <nct_id>NCT03799978</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects</brief_title>
  <official_title>A Single-center, Open-label, Randomized, Two Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Idorsia Pharmaceuticals Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Idorsia Pharmaceuticals Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, open-label, randomized, two way crossover study to investigate the&#xD;
      food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2019</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</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>
    <intervention_model_description>Two way crossover</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic endpoint: AUC0-24</measure>
    <time_frame>Multiple timepoints; duration: up to 48 hours in each treatment period</time_frame>
    <description>Area under the plasma concentration-time curve (AUC) from time zero to 24 h</description>
  </primary_outcome>
  <other_outcome>
    <measure>Pharmacokinetic endpoint: AUC0-inf</measure>
    <time_frame>Multiple timepoints; duration: up to 48 hours in each treatment period</time_frame>
    <description>AUC from time zero to infinity</description>
  </other_outcome>
  <other_outcome>
    <measure>Pharmacokinetic endpoint: Cmax</measure>
    <time_frame>Multiple timepoints; duration: up to 48 hours in each treatment period</time_frame>
    <description>Maximum plasma concentration</description>
  </other_outcome>
  <other_outcome>
    <measure>Pharmacokinetic endpoint: tmax</measure>
    <time_frame>Multiple timepoints; duration: up to 48 hours in each treatment period</time_frame>
    <description>Time to reach maximum plasma concentration</description>
  </other_outcome>
  <other_outcome>
    <measure>Pharmacokinetic endpoint: t½</measure>
    <time_frame>Multiple timepoints; duration: up to 48 hours in each treatment period</time_frame>
    <description>Terminal elimination half-life</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment-emergent adverse events</measure>
    <time_frame>From study treatment administration up to EOT; duration: up to 48 hours in each treatment period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serious treatment-emergent adverse events</measure>
    <time_frame>From study treatment administration up to EOT; duration: up to 48 hours in each treatment period</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A: ACT-541468 50 mg under fasted conditions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose administered on Day 1 under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B: ACT-541468 50 mg under fed conditions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose administered on Day 1 administered after food intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541468</intervention_name>
    <description>ACT-541468 50 mg film-coated tablets</description>
    <arm_group_label>Treatment A: ACT-541468 50 mg under fasted conditions</arm_group_label>
    <arm_group_label>Treatment B: ACT-541468 50 mg under fed conditions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent prior to any study-mandated procedure&#xD;
&#xD;
          -  Healthy male subjects aged between 18 and 45 years (inclusive) at Screening&#xD;
&#xD;
          -  Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening&#xD;
&#xD;
          -  No clinically relevant findings on the physical examination at Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of major medical or surgical disorders, which, in the opinion of the&#xD;
             investigator, are likely to interfere with the absorption, distribution, metabolism,&#xD;
             or excretion of the study treatments (appendectomy and herniotomy allowed,&#xD;
             cholecystectomy not allowed)&#xD;
&#xD;
          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect&#xD;
             full participation in the study or compliance with the protocol&#xD;
&#xD;
          -  Modified Swiss Narcolepsy Scale total score &lt; 0 at screening or history of narcolepsy&#xD;
             or cataplexy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Idorsia Pharmaceuticals Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CEPHA s.r.o.</name>
      <address>
        <city>Pilsen</city>
        <zip>323 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03799978
org study id: ID-078-113
nct id: NCT03799978
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single-center, open-label, randomized, two way crossover study to investigate the
      food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Two way crossover
primary purpose: Other
masking: None (Open Label)
measure: Pharmacokinetic endpoint: AUC0-24
time frame: Multiple timepoints; duration: up to 48 hours in each treatment period
description: Area under the plasma concentration-time curve (AUC) from time zero to 24 h
measure: Pharmacokinetic endpoint: AUC0-inf
time frame: Multiple timepoints; duration: up to 48 hours in each treatment period
description: AUC from time zero to infinity
measure: Pharmacokinetic endpoint: Cmax
time frame: Multiple timepoints; duration: up to 48 hours in each treatment period
description: Maximum plasma concentration
measure: Pharmacokinetic endpoint: tmax
time frame: Multiple timepoints; duration: up to 48 hours in each treatment period
description: Time to reach maximum plasma concentration
measure: Pharmacokinetic endpoint: t½
time frame: Multiple timepoints; duration: up to 48 hours in each treatment period
description: Terminal elimination half-life
measure: Treatment-emergent adverse events
time frame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period
measure: Serious treatment-emergent adverse events
time frame: From study treatment administration up to EOT; duration: up to 48 hours in each treatment period
arm group label: Treatment A: ACT-541468 50 mg under fasted conditions
arm group type: Experimental
description: Single oral dose administered on Day 1 under fasted conditions.
arm group label: Treatment B: ACT-541468 50 mg under fed conditions
arm group type: Experimental
description: Single oral dose administered on Day 1 administered after food intake.
intervention type: Drug
intervention name: ACT-541468
description: ACT-541468 50 mg film-coated tablets
arm group label: Treatment A: ACT-541468 50 mg under fasted conditions
arm group label: Treatment B: ACT-541468 50 mg under fed conditions
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Idorsia Pharmaceuticals Ltd.
facility: 
country: Czechia
responsible party type: Sponsor
sharing ipd: No