<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/NCT01688089</url>
  </required_header>
  <id_info>
    <org_study_id>3109001</org_study_id>
    <nct_id>NCT01688089</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers</brief_title>
  <acronym>NOCOS</acronym>
  <official_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-103: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of escalating doses of&#xD;
      ODM-103 when given to healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is divided into two parts. Part one is a crossover study where healthy volunteers&#xD;
      will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple&#xD;
      ascending dose parallel group study where healthy volunteers will receive ODM-103 three times&#xD;
      daily for seven days. Healthy volunteers taking part in Part II of the study will also&#xD;
      receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in&#xD;
      addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body&#xD;
      handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.</measure>
    <time_frame>0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose</time_frame>
    <description>Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration curve (AUC)</measure>
    <time_frame>0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose</time_frame>
    <description>AUC under the plasma concentration curve</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ODM-103</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral capsules given once daily for one day or three times daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>entacapone + levodopa/carbidopa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ODM103</intervention_name>
    <arm_group_label>ODM-103</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entacapone</intervention_name>
    <arm_group_label>entacapone + levodopa/carbidopa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levodopa/carbidopa</intervention_name>
    <arm_group_label>entacapone + levodopa/carbidopa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects aged between 18 and 45 years&#xD;
&#xD;
          -  BMI 18-30 kg/m2&#xD;
&#xD;
          -  Weight 55-90kg&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Good General Health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable subjects&#xD;
&#xD;
          -  Veins unsuitable for repeated venipuncture&#xD;
&#xD;
          -  Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi,&#xD;
             pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder&#xD;
&#xD;
          -  History of or positive test for drug abuse&#xD;
&#xD;
          -  Any condition requiring regular concomitant medication&#xD;
&#xD;
          -  Blood donation or significant loss of blood within 3 months prior to screening&#xD;
&#xD;
          -  Abnormal 12 lead ECG finding of clinical relevance&#xD;
&#xD;
          -  Heart rate (HR) &lt;50bpm or &gt;90bpm after 10 minutes in a supine position&#xD;
&#xD;
          -  Systolic blood pressure &lt;90mmHg or &gt;140mmHg after 10 minutes in a supine position&#xD;
&#xD;
          -  Diastolic blood pressure &lt;50mmHg or &gt;90mmHg after 10 minutes in a supine position&#xD;
&#xD;
          -  Abnormal 24 hour Holter recording of clinical relevance at screening&#xD;
&#xD;
          -  Any abnormal laboratory value, vital signs or physical examination causing a health&#xD;
             risk to the volunteer&#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>Rainard Fuhr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parexel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel International GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>volunteer</keyword>
  <keyword>study</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levodopa</mesh_term>
    <mesh_term>Carbidopa</mesh_term>
    <mesh_term>Entacapone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01688089
org study id: 3109001
nct id: NCT01688089
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and tolerability of escalating doses of
      ODM-103 when given to healthy male volunteers.
The study is divided into two parts. Part one is a crossover study where healthy volunteers
      will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple
      ascending dose parallel group study where healthy volunteers will receive ODM-103 three times
      daily for seven days. Healthy volunteers taking part in Part II of the study will also
      receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in
      addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body
      handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
time frame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
description: Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
measure: Area under the plasma concentration curve (AUC)
time frame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
description: AUC under the plasma concentration curve
arm group label: ODM-103
arm group type: Experimental
description: Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral capsules given once daily for one day or three times daily for 7 days
arm group label: entacapone + levodopa/carbidopa
arm group type: Active Comparator
description: entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day
intervention type: Drug
intervention name: ODM103
arm group label: ODM-103
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Entacapone
arm group label: entacapone + levodopa/carbidopa
intervention type: Drug
intervention name: Levodopa/carbidopa
arm group label: entacapone + levodopa/carbidopa
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rainard Fuhr, MD
role: Principal Investigator
affiliation: Parexel
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Levodopa
mesh term: Carbidopa
mesh term: Entacapone