<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/NCT04451811</url>
  </required_header>
  <id_info>
    <org_study_id>OPL-002-102</org_study_id>
    <nct_id>NCT04451811</nct_id>
  </id_info>
  <brief_title>A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers</brief_title>
  <official_title>A Pharmacokinetic Dose Proportionality Study of OPL-002 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oppilan Pharma Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celerion</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Oppilan Pharma 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, randomized, open-label, three-way crossover, single dose,&#xD;
      pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2020</start_date>
  <completion_date type="Actual">February 24, 2021</completion_date>
  <primary_completion_date type="Actual">February 24, 2021</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>AUC of OPL-002</measure>
    <time_frame>0 to 48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose proportionality of 5 and 20 mg</measure>
    <time_frame>0 to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute lymphocyte count</measure>
    <time_frame>0 to 48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>OPL-002 SDD 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg SDD formulation of OPL-002</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPL-002 5 mg Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg tablet formulation of OPL-002</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPL-002 20 mg Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg tablet formulation of OPL-002</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPL-002</intervention_name>
    <description>Spray dried dispersion and tablet formulation</description>
    <arm_group_label>OPL-002 20 mg Tablet</arm_group_label>
    <arm_group_label>OPL-002 5 mg Tablet</arm_group_label>
    <arm_group_label>OPL-002 SDD 20 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female (of non-childbearing potential only) between 18 and 55 years of age.&#xD;
&#xD;
          -  Females must be of non-childbearing potential and must have undergone one of the&#xD;
             following sterilization procedures, and have official documentation, at least 6 months&#xD;
             prior to the first dose:&#xD;
&#xD;
               1. hysteroscopic sterilization;&#xD;
&#xD;
               2. bilateral tubal ligation or bilateral salpingectomy;&#xD;
&#xD;
               3. hysterectomy;&#xD;
&#xD;
               4. bilateral oophorectomy, or;&#xD;
&#xD;
               5. be postmenopausal with amenorrhea for at least 1 year prior to the first dose and&#xD;
                  have FSH serum levels consistent with postmenopausal status as per investigator&#xD;
                  judgment.&#xD;
&#xD;
          -  Male subjects must use reliable forms of contraception from screening to 30 days after&#xD;
             the end of dosing.&#xD;
&#xD;
          -  Good general health as determined by medical history, and by results of physical&#xD;
             examination, vital signs, ECG, and clinical laboratory tests obtained within 28 days&#xD;
             (4 weeks) prior to study drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of any clinically significant organ system disease that could&#xD;
             interfere with the objectives of the study or the safety of the subjects.&#xD;
&#xD;
          -  pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg&#xD;
             diastolic, heart rate 60-100 beats/min.&#xD;
&#xD;
          -  12-lead ECG with any abnormality judged by the Investigator to be clinically&#xD;
             significant, QRS &gt;= 110 milliseconds (msec), QT/QTcF interval of &gt; 450 msec for men or&#xD;
             &gt;470 msec for women, or PR &gt; 200 msec.&#xD;
&#xD;
          -  Presence or history of any abnormality or illness, which in the opinion of the&#xD;
             Investigator may affect absorption, distribution, metabolism or elimination of the&#xD;
             study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Gregg, MD</last_name>
    <role>Study Director</role>
    <affiliation>Oppilan Pharma Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <zip>BT9 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</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/NCT04451811
org study id: OPL-002-102
nct id: NCT04451811
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single center, randomized, open-label, three-way crossover, single dose,
      pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUC of OPL-002
time frame: 0 to 48 hours
measure: Dose proportionality of 5 and 20 mg
time frame: 0 to 48 hours
measure: Absolute lymphocyte count
time frame: 0 to 48 hours
arm group label: OPL-002 SDD 20 mg
arm group type: Experimental
description: 20 mg SDD formulation of OPL-002
arm group label: OPL-002 5 mg Tablet
arm group type: Experimental
description: 5 mg tablet formulation of OPL-002
arm group label: OPL-002 20 mg Tablet
arm group type: Experimental
description: 20 mg tablet formulation of OPL-002
intervention type: Drug
intervention name: OPL-002
description: Spray dried dispersion and tablet formulation
arm group label: OPL-002 20 mg Tablet
arm group label: OPL-002 5 mg Tablet
arm group label: OPL-002 SDD 20 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Gregg, MD
role: Study Director
affiliation: Oppilan Pharma Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No