<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/NCT03240445</url>
  </required_header>
  <id_info>
    <org_study_id>3113004</org_study_id>
    <nct_id>NCT03240445</nct_id>
  </id_info>
  <brief_title>Impact of Changing the Dosing Regimen on the PK Profile of ODM-203</brief_title>
  <acronym>KIPEV</acronym>
  <official_title>A Part-randomised, Single Centre, Single Dose, Crossover,Phase I Study to Investigate the Impact of Changes to the Dosing Regimen on the Pharmacokinetic Profile of ODM-203 in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quotient Clinical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase I study in healthy male volunteers will evaluate the impact of the effect of food&#xD;
      on the pharmacokinetic profile of ODM-203.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single dose part randomised cross over study with up to 6 study periods.&#xD;
      ODM-203 may be dosed using a variety of different conditions with respect to food depending&#xD;
      on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to&#xD;
      determine the PK of alternative formulations and identify appropriate drug formulations for&#xD;
      further development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">October 23, 2017</completion_date>
  <primary_completion_date type="Actual">October 23, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food</measure>
    <time_frame>0 to 72 hours</time_frame>
    <description>Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>From the date of informed consent to the date of the end of study estimated to be up to 17 weeks</time_frame>
    <description>Number of adverse events counts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food</measure>
    <time_frame>0 to 72 hours</time_frame>
    <description>Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ORM-21444 in the presence and absence of food</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ODM-203 dosed after food</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ODM-203 dosed before food</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periods 3-6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ODM-203 dosed as a tablet or dispersion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ODM-203 (Period 1)</intervention_name>
    <description>ODM-203 400mg as tablets taken 30 minutes after food</description>
    <arm_group_label>Period 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ODM-203 (Period 2)</intervention_name>
    <description>ODM-203 400mg as tablets taken 1 hour before a light breakfast</description>
    <arm_group_label>Period 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ODM-203 (Periods 3-6)</intervention_name>
    <description>ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food</description>
    <arm_group_label>Periods 3-6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Able to speak, write and understand English&#xD;
&#xD;
          -  Body mass index of 18.0-32.0&#xD;
&#xD;
          -  Weight 55-95 kg&#xD;
&#xD;
          -  Adequate method of contraception&#xD;
&#xD;
          -  Good state of health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of IMP in a clinical research study or donation/loss of &gt;400ml blood within&#xD;
             previous 3 months or previously enrolled in this study&#xD;
&#xD;
          -  History of drug or alcohol abuse or positive drugs of abuse test or regular alcohol&#xD;
             consumption or current smoker/user of nicotine replacement products&#xD;
&#xD;
          -  Positive drugs of abuse test&#xD;
&#xD;
          -  Positive hepatitis B, hepatitis C or HIV results&#xD;
&#xD;
          -  Donation/loss of &gt;400ml blood within previous 3 months&#xD;
&#xD;
          -  Poor compliance or inability to follow protocol&#xD;
             requirements/instructions/restrictions.&#xD;
&#xD;
          -  Vulnerable subjects&#xD;
&#xD;
          -  Evidence of clinically relevant disease of any body system including relevant&#xD;
             psychiatric disorders or conditions requiring regular concomitant medication&#xD;
&#xD;
          -  History of significant hypersensitivity, anaphylaxis, intolerance to drugs/food&#xD;
&#xD;
          -  Propensity to get headaches when refraining from caffeine containing beverages&#xD;
&#xD;
          -  Any abnormal laboratory value, vital signs, ECG parameter or physical examination&#xD;
             interfering with the test results or causing a health risk for the subject or failure&#xD;
             to satisfy the investigator of fitness to participate for any other reason.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clare Preskey, BSc</last_name>
    <role>Study Director</role>
    <affiliation>Quotient Clinical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical Ltd</name>
      <address>
        <city>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 17, 2019</submitted>
    <returned>October 10, 2019</returned>
    <submitted>January 20, 2020</submitted>
    <returned>January 29, 2020</returned>
    <submitted>March 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03240445
org study id: 3113004
nct id: NCT03240445
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This Phase I study in healthy male volunteers will evaluate the impact of the effect of food
      on the pharmacokinetic profile of ODM-203.
This study will be a single dose part randomised cross over study with up to 6 study periods.
      ODM-203 may be dosed using a variety of different conditions with respect to food depending
      on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to
      determine the PK of alternative formulations and identify appropriate drug formulations for
      further development.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
time frame: 0 to 72 hours
description: Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food
measure: Number of adverse events
time frame: From the date of informed consent to the date of the end of study estimated to be up to 17 weeks
description: Number of adverse events counts
measure: Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food
time frame: 0 to 72 hours
description: Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ORM-21444 in the presence and absence of food
arm group label: Period 1
arm group type: Experimental
description: ODM-203 dosed after food
arm group label: Period 2
arm group type: Experimental
description: ODM-203 dosed before food
arm group label: Periods 3-6
arm group type: Experimental
description: ODM-203 dosed as a tablet or dispersion
intervention type: Drug
intervention name: ODM-203 (Period 1)
description: ODM-203 400mg as tablets taken 30 minutes after food
arm group label: Period 1
intervention type: Drug
intervention name: ODM-203 (Period 2)
description: ODM-203 400mg as tablets taken 1 hour before a light breakfast
arm group label: Period 2
intervention type: Drug
intervention name: ODM-203 (Periods 3-6)
description: ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
arm group label: Periods 3-6
criteria: 
gender: Male
gender based: Yes
gender description: Healthy male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clare Preskey, BSc
role: Study Director
affiliation: Quotient Clinical
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided
submitted: September 17, 2019
returned: October 10, 2019
submitted: January 20, 2020
returned: January 29, 2020
submitted: March 20, 2023