<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/NCT03231124</url>
  </required_header>
  <id_info>
    <org_study_id>LP0058-1362</org_study_id>
    <secondary_id>2017-000907-26</secondary_id>
    <nct_id>NCT03231124</nct_id>
  </id_info>
  <brief_title>Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.</brief_title>
  <official_title>A Phase 1, Single Centre Randomised, Double-blind Placebo-controlled Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <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 trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO&#xD;
      32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary&#xD;
      objective is the assessment of PK in Japanese subjects.&#xD;
&#xD;
      Data obtained from this trial will be used to compare with existing data from the other Phase&#xD;
      1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects&#xD;
      will allow the inclusion of Japanese patients into Phase 2b studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">August 22, 2017</completion_date>
  <primary_completion_date type="Actual">August 22, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>LEO 32731 and Placebo tablets are of identical appearance. The packaging and labelling of the IMPs and Placebo contain no evidence of their identity. It is not considered possible to differentiate between the IMPs solely by sensory evaluation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731.</measure>
    <time_frame>on Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach maximum observed plasma concentration (tmax) on day 12 of LEO 32731.</measure>
    <time_frame>on Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) on day 12 of LEO 32731.</measure>
    <time_frame>on Day 12</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>LEO 32731</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Incremental dosing of LEO 32731 progressing to a maximum of 30 mg.&#xD;
Days 1 - 3: 10 mg dose twice a day for three days&#xD;
Days 4 - 6: 20 mg dose twice a day for three days&#xD;
Days 7 - 11: 30 mg dose twice a day for five days&#xD;
Days 12: 30 mg dose once in the morning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Incremental dosing of placebo progressing to a maximum of 30 mg.&#xD;
Days 1 - 3: 10 mg dose twice a day for three days&#xD;
Days 4 - 6: 20 mg dose twice a day for three days&#xD;
Days 7 - 11: 30 mg dose twice a day for five days&#xD;
Days 12: 30 mg dose once in the morning</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731</intervention_name>
    <description>LEO 32731 is being developed by LEO Pharma.</description>
    <arm_group_label>LEO 32731</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo contains the same excipients in the same concentration, only lacking LEO 32731</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide written, personally signed, and dated informed consent to&#xD;
             participate in the study, in accordance with the ICH Good Clinical Practice (GCP)&#xD;
             Guideline E6 (1996) and applicable regulations, before completing any study-related&#xD;
             procedures.&#xD;
&#xD;
          2. An understanding, willingness and ability to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          3. Japanese men aged &gt;20 to &lt;45 years (from date of signing informed consent which is&#xD;
             defined as the beginning of the Screening Period). This inclusion criterion will only&#xD;
             be assessed at the Screening Visit.&#xD;
&#xD;
          4. Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first&#xD;
             generation Japanese, defined as born in Japan and having 4 biologic grandparents who&#xD;
             are ethnic Japanese.&#xD;
&#xD;
          5. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or recurrent disease (i.e. with, or with a history of, any clinically&#xD;
             significant neurological, gastrointestinal, renal, hepatic, cardiovascular,&#xD;
             psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or&#xD;
             other major disorders as determined by the Investigator) that could affect the action,&#xD;
             absorption, or disposition of LEO 32731, or could affect clinical assessments or&#xD;
             clinical laboratory evaluations.&#xD;
&#xD;
          2. Current or relevant history of physical or psychiatric illness that may require&#xD;
             treatment or make the subject unlikely to fully comply with the requirements of the&#xD;
             study or complete the study, or any condition that presents undue risk from the&#xD;
             investigational product or study procedures.&#xD;
&#xD;
          3. Any history of psychiatric or mental health issue such (including depression) deemed&#xD;
             clinically significant as assessed by the Investigator.&#xD;
&#xD;
          4. Any history of/or active cancer or malignancy (other than squamous cell carcinoma more&#xD;
             than 5 years prior).&#xD;
&#xD;
          5. History of Wiskott-Aldrich Syndrome&#xD;
&#xD;
          6. History of active tuberculosis, and/or history of partially or incomplete treatment of&#xD;
             tuberculosis.&#xD;
&#xD;
          7. Any other significant disease or disorder which, in the opinion of the investigator,&#xD;
             may either put the subject at risk because of participation in the study, may&#xD;
             influence the result of the study, or the subject's ability to participate in the&#xD;
             study.&#xD;
&#xD;
          8. Use of any prescribed systemic or topical medication(s) within 14 days or 10&#xD;
             half-lives (whichever is longer) prior to Day 1 of the dosing period.&#xD;
&#xD;
          9. Use of any systemic or topical non-prescribed or over-the-counter (OTC) medication(s)&#xD;
             (including multivitamin, herbal, or homeopathic preparations) within 7 days or 5&#xD;
             half-lives (whichever is longer) prior to Day 1 of the dosing period. The occasional&#xD;
             use of paracetamol (acetaminophen) is allowed to treat short term adverse events;&#xD;
             subject to review by the investigator. The maximum allowed daily dose is 2000 mg for&#xD;
             paracetamol at the discretion of the investigator.&#xD;
&#xD;
         10. Consumption of more than 21 units of alcohol per week.&#xD;
&#xD;
         11. History or clinical evidence of substance and/or alcohol abuse within the 12 months&#xD;
             before screening. Alcohol abuse is defined as regular weekly intake of more than 21&#xD;
             units for males.&#xD;
&#xD;
         12. Positive test results for alcohol, drugs of abuse at screening or Day -1.&#xD;
&#xD;
         13. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing&#xD;
             products in any form (e.g., gum, patch) within 90 days prior to Day 1 of the dosing&#xD;
             period.&#xD;
&#xD;
         14. Use of an investigational product within 90 days prior to Day 1 of the dosing period&#xD;
             or active enrolment in another drug or vaccine clinical study.&#xD;
&#xD;
         15. Known or suspected intolerance, hypersensitivity or allergy (excluding non-active&#xD;
             hayfever) to any drug, food or other known substance (including investigational&#xD;
             product, its closely related compounds, and/or any of the stated ingredients).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrike Lorch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richmond Pharmacology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SE1 1YR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_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/NCT03231124
org study id: LP0058-1362
secondary id: 2017-000907-26
nct id: NCT03231124
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO
      32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary
      objective is the assessment of PK in Japanese subjects.

      Data obtained from this trial will be used to compare with existing data from the other Phase
      1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects
      will allow the inclusion of Japanese patients into Phase 2b studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: LEO 32731 and Placebo tablets are of identical appearance. The packaging and labelling of the IMPs and Placebo contain no evidence of their identity. It is not considered possible to differentiate between the IMPs solely by sensory evaluation.
measure: Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731.
time frame: on Day 12
measure: Time to reach maximum observed plasma concentration (tmax) on day 12 of LEO 32731.
time frame: on Day 12
measure: Maximum observed plasma concentration (Cmax) on day 12 of LEO 32731.
time frame: on Day 12
arm group label: LEO 32731
arm group type: Experimental
description: Incremental dosing of LEO 32731 progressing to a maximum of 30 mg.
Days 1 - 3: 10 mg dose twice a day for three days
Days 4 - 6: 20 mg dose twice a day for three days
Days 7 - 11: 30 mg dose twice a day for five days
Days 12: 30 mg dose once in the morning
arm group label: Placebo
arm group type: Placebo Comparator
description: Incremental dosing of placebo progressing to a maximum of 30 mg.
Days 1 - 3: 10 mg dose twice a day for three days
Days 4 - 6: 20 mg dose twice a day for three days
Days 7 - 11: 30 mg dose twice a day for five days
Days 12: 30 mg dose once in the morning
intervention type: Drug
intervention name: LEO 32731
description: LEO 32731 is being developed by LEO Pharma.
arm group label: LEO 32731
intervention type: Drug
intervention name: Placebo
description: Placebo contains the same excipients in the same concentration, only lacking LEO 32731
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulrike Lorch, MD
role: Principal Investigator
affiliation: Richmond Pharmacology
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Psoriasis