<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/NCT03812198</url>
  </required_header>
  <id_info>
    <org_study_id>LP0058-1442</org_study_id>
    <secondary_id>2018-003282-34</secondary_id>
    <nct_id>NCT03812198</nct_id>
  </id_info>
  <brief_title>A Trial to Investigate the Safety, Tolerability, and Drug Levels in Blood After Single and Multiple Doses of LEO 32731 in Healthy People</brief_title>
  <official_title>A Phase 1, 3-part, Single (Open-label) and Multiple (Double-blind, Placebo-controlled) Oral Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of LEO 32731 Formulations in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4&#xD;
      different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in&#xD;
      3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will&#xD;
      participate in 3 treatment periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1 will evaluate the pharmacokinetics of single doses of 4 test formulations of LEO 32731&#xD;
      compared with a reference formulation. Part 2 will evaluate the effect of food on the&#xD;
      pharmacokinetics of selected test formulations of LEO 32731. Part 3 will evaluate the&#xD;
      tolerability and safety of selected test formulations of LEO 32731 after multiple dosing.&#xD;
&#xD;
      Based on data from Part 1, up to 3 formulations will be taken forward to Part 2. If none of&#xD;
      the formulations are considered appropriate to take forward to Part 2, the trial will stop&#xD;
      after Part 1. Similarly, based on data from Part 2, up to 2 formulations will be taken&#xD;
      forward to Part 3. If none of the formulations are considered appropriate to take forward to&#xD;
      Part 3, the trial will stop after Part 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">June 13, 2019</completion_date>
  <primary_completion_date type="Actual">June 13, 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>Sequential Assignment</intervention_model>
    <intervention_model_description>Part 1 (single dose, cross-over) Part 2 (single dose, cross-over with food effect evaluation) Part 3 (multiple dose, parallel)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>3-part, single (open-label) and multiple (double-blind, placebo-controlled)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1. AUC0-∞</measure>
    <time_frame>Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1</time_frame>
    <description>AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1. Relative bioavailability (F-rel)</measure>
    <time_frame>Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1</time_frame>
    <description>F-rel: AUC0 ∞ test formulations/AUC0-∞ reference formulation (derived from the statistical analysis of AUC0-∞)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1. C-max</measure>
    <time_frame>Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1</time_frame>
    <description>C-max: Maximum observed plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1. t-max</measure>
    <time_frame>Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1</time_frame>
    <description>t-max: Time to reach maximum observed plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2. AUC0-∞</measure>
    <time_frame>Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2</time_frame>
    <description>AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2. Relative bioavailability (F-rel)</measure>
    <time_frame>Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2</time_frame>
    <description>F-rel: AUC0 ∞ test formulations/AUC0-∞ reference formulation (derived from the statistical analysis of AUC0-∞)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2. C-max</measure>
    <time_frame>Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2</time_frame>
    <description>C-max: Maximum observed plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2. t-max</measure>
    <time_frame>Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2</time_frame>
    <description>t-max: Time to reach maximum observed plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3. Number of GI-related AEs and number of subjects with GI-related AEs during the treatment period</measure>
    <time_frame>From Day 1 (first dose) to Day 19 (end of treatment period) in Part 3</time_frame>
    <description>AEs: adverse events; GI: gastrointestinal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and period.</measure>
    <time_frame>24 days (from first dose in first treatment period until end of last treatment period) in Part 1</time_frame>
    <description>AEs: adverse events; GI: gastrointestinal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of total AEs and number of subjects with AEs during each combination of treatment and period</measure>
    <time_frame>24 days (from first dose in first treatment period until end of last treatment period) in Part 1</time_frame>
    <description>AEs: adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose</time_frame>
    <description>Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose</time_frame>
    <description>Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose</time_frame>
    <description>Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose</time_frame>
    <description>Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1</time_frame>
    <description>Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1</time_frame>
    <description>Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1</time_frame>
    <description>QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. AUC0-t</measure>
    <time_frame>Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1</time_frame>
    <description>AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1. t1/2</measure>
    <time_frame>Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1</time_frame>
    <description>t1/2: apparent terminal half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and period.</measure>
    <time_frame>28 days (from first dose in first treatment period until end of last treatment period) in Part 2</time_frame>
    <description>AEs: adverse events; GI: gastrointestinal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of total AEs and number of subjects with AEs during each combination of treatment and period</measure>
    <time_frame>28 days (from first dose in first treatment period until end of last treatment period) in Part 2</time_frame>
    <description>AEs: adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose</time_frame>
    <description>Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose</time_frame>
    <description>Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose</time_frame>
    <description>Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose</time_frame>
    <description>Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2</time_frame>
    <description>Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2</time_frame>
    <description>Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2</time_frame>
    <description>QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. AUC0-t</measure>
    <time_frame>Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2</time_frame>
    <description>AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2. t1/2</measure>
    <time_frame>Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2</time_frame>
    <description>t1/2: apparent terminal half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. AUC0-∞</measure>
    <time_frame>Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3</time_frame>
    <description>AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. C-max</measure>
    <time_frame>Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3</time_frame>
    <description>C-max: Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. t-max</measure>
    <time_frame>Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3</time_frame>
    <description>t-max: Time to reach maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. AUC0-t</measure>
    <time_frame>Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3</time_frame>
    <description>AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. t1/2</measure>
    <time_frame>Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3</time_frame>
    <description>t1/2: apparent terminal half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of total AEs and number of subjects with AEs during the treatment period</measure>
    <time_frame>From Day 1 (first dose) to Day 19 (end of treatment period) in Part 3</time_frame>
    <description>AEs: adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'</measure>
    <time_frame>At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)</time_frame>
    <description>QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group 1-1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Part 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation/treatment period): LEO 32731 modified release tablet; LEO 32731 blend, hard capsule; LEO 32731 API hard capsule (reference formulation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1-2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Part 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation/treatment period): LEO 32731 soft capsule; LEO 32731 gastro-resistant capsule; LEO 32731 API hard capsule (reference formulation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast.&#xD;
The formulation depends on the outcome of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast.&#xD;
The formulation depends on the outcome of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast.&#xD;
The formulation depends on the outcome of Part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3-1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3-2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731 modified release tablet</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 1-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731 blend, hard capsule</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 1-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731 API, hard capsule</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 1-1</arm_group_label>
    <arm_group_label>Group 1-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731 soft capsule</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 1-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731 gastro-resistant capsule</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 1-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 32731</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 2-1</arm_group_label>
    <arm_group_label>Group 2-2</arm_group_label>
    <arm_group_label>Group 2-3</arm_group_label>
    <arm_group_label>Group 3-1</arm_group_label>
    <arm_group_label>Group 3-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.</description>
    <arm_group_label>Group 3-1</arm_group_label>
    <arm_group_label>Group 3-2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key inclusion criteria:&#xD;
&#xD;
          -  Age 18 to 65 years, inclusive.&#xD;
&#xD;
          -  Body mass index of 18.5 to 29.9 kg/m2, inclusive.&#xD;
&#xD;
          -  In good health, at the discretion of the investigator, as determined by: medical&#xD;
             history, physical examination, vital sign assessment (specifically, blood pressure&#xD;
             must be within normal reference range), 12-lead ECG, clinical laboratory evaluations,&#xD;
             aspartate aminotransferase and alanine aminotransferase not above the upper limit of&#xD;
             normal (Gilbert's syndrome is not acceptable).&#xD;
&#xD;
          -  Female subjects of childbearing potential must be willing to use a highly effective&#xD;
             form of birth control in conjunction with a barrier method of contraception throughout&#xD;
             the trial and for at least 90 days after final follow-up.&#xD;
&#xD;
          -  Male subjects with a female partner of childbearing potential must be willing to use a&#xD;
             highly effective form of birth control in conjunction with male barrier method of&#xD;
             contraception (i.e. male condom with spermicide) throughout the trial and for at least&#xD;
             90 days after final follow-up.&#xD;
&#xD;
        Key exclusion criteria:&#xD;
&#xD;
          -  Systemic or topical treatment within 14 days prior to first dose administration unless&#xD;
             in the opinion of the investigator the medication will not interfere with the trial&#xD;
             procedures or compromise safety.&#xD;
&#xD;
          -  Any medications, including St. John's wort, known to chronically alter drug absorption&#xD;
             or elimination processes within 30 days prior to first dose administration.&#xD;
&#xD;
          -  Subjects who smoke more than an average of 10 cigarettes per day.&#xD;
&#xD;
          -  History of chronic alcohol or drug abuse within 12 months prior to screening.&#xD;
&#xD;
          -  Subjects with ≥3 bowel movements per day.&#xD;
&#xD;
          -  Any disorder which is not stable and could: Affect the safety of the subject&#xD;
             throughout the trial; Influence the findings of the trial; Impede the subject's&#xD;
             ability to complete the trial. Examples include but are not limited to cardiovascular,&#xD;
             GI, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic,&#xD;
             haematological, immunological, and psychiatric disorders and major physical&#xD;
             impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Expert</last_name>
    <role>Study Director</role>
    <affiliation>LEO Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LEO Pharma Investigational Site</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>June 28, 2019</last_update_submitted>
  <last_update_submitted_qc>June 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>External researchers with no commercial interest who provide scientifically sound research proposal</ipd_access_criteria>
    <ipd_url>http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx</ipd_url>
  </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/NCT03812198
org study id: LP0058-1442
secondary id: 2018-003282-34
nct id: NCT03812198
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4
      different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in
      3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will
      participate in 3 treatment periods.
Part 1 will evaluate the pharmacokinetics of single doses of 4 test formulations of LEO 32731
      compared with a reference formulation. Part 2 will evaluate the effect of food on the
      pharmacokinetics of selected test formulations of LEO 32731. Part 3 will evaluate the
      tolerability and safety of selected test formulations of LEO 32731 after multiple dosing.

      Based on data from Part 1, up to 3 formulations will be taken forward to Part 2. If none of
      the formulations are considered appropriate to take forward to Part 2, the trial will stop
      after Part 1. Similarly, based on data from Part 2, up to 2 formulations will be taken
      forward to Part 3. If none of the formulations are considered appropriate to take forward to
      Part 3, the trial will stop after Part 2.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Part 1 (single dose, cross-over) Part 2 (single dose, cross-over with food effect evaluation) Part 3 (multiple dose, parallel)
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: 3-part, single (open-label) and multiple (double-blind, placebo-controlled)
measure: Part 1. AUC0-∞
time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1
description: AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity
measure: Part 1. Relative bioavailability (F-rel)
time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1
description: F-rel: AUC0 ∞ test formulations/AUC0-∞ reference formulation (derived from the statistical analysis of AUC0-∞)
measure: Part 1. C-max
time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1
description: C-max: Maximum observed plasma concentration
measure: Part 1. t-max
time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1
description: t-max: Time to reach maximum observed plasma concentration
measure: Part 2. AUC0-∞
time frame: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2
description: AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity
measure: Part 2. Relative bioavailability (F-rel)
time frame: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2
description: F-rel: AUC0 ∞ test formulations/AUC0-∞ reference formulation (derived from the statistical analysis of AUC0-∞)
measure: Part 2. C-max
time frame: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2
description: C-max: Maximum observed plasma concentration
measure: Part 2. t-max
time frame: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2
description: t-max: Time to reach maximum observed plasma concentration
measure: Part 3. Number of GI-related AEs and number of subjects with GI-related AEs during the treatment period
time frame: From Day 1 (first dose) to Day 19 (end of treatment period) in Part 3
description: AEs: adverse events; GI: gastrointestinal
measure: Part 1. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and period.
time frame: 24 days (from first dose in first treatment period until end of last treatment period) in Part 1
description: AEs: adverse events; GI: gastrointestinal
measure: Part 1. Number of total AEs and number of subjects with AEs during each combination of treatment and period
time frame: 24 days (from first dose in first treatment period until end of last treatment period) in Part 1
description: AEs: adverse events
measure: Part 1. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose
description: Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose
description: Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose
description: Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 1: predose, 4 hours, 24 hours, and 48 hours postdose
description: Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1
description: Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1
description: Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening, predose in Treatment period 1, and 48 hours postdose in Treatment period 3 in Part 1
description: QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator
measure: Part 1. AUC0-t
time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1
description: AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
measure: Part 1. t1/2
time frame: Calculated using concentration data collected from predose to 48 hours postdose for each treatment period in Part 1
description: t1/2: apparent terminal half-life
measure: Part 2. Number of GI-related AEs and number of subjects with GI-related AEs during each combination of treatment and period.
time frame: 28 days (from first dose in first treatment period until end of last treatment period) in Part 2
description: AEs: adverse events; GI: gastrointestinal
measure: Part 2. Number of total AEs and number of subjects with AEs during each combination of treatment and period
time frame: 28 days (from first dose in first treatment period until end of last treatment period) in Part 2
description: AEs: adverse events
measure: Part 2. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose
description: Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose
description: Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose
description: Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during each treatment period in Part 2: predose, 4 hours, 24 hours, and 72 hours postdose
description: Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2
description: Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2
description: Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening, predose in Treatment period 1, and 72 hours postdose in Treatment period 3 in Part 2
description: QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator
measure: Part 2. AUC0-t
time frame: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2
description: AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
measure: Part 2. t1/2
time frame: Calculated using concentration data collected from predose to 72 hours postdose for each treatment period in Part 2
description: t1/2: apparent terminal half-life
measure: Part 3. AUC0-∞
time frame: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3
description: AUC0-∞: Area under the plasma concentration-time curve from time 0 extrapolated to infinity
measure: Part 3. C-max
time frame: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3
description: C-max: Maximum observed plasma concentration
measure: Part 3. t-max
time frame: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3
description: t-max: Time to reach maximum observed plasma concentration
measure: Part 3. AUC0-t
time frame: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3
description: AUC0-t: area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration
measure: Part 3. t1/2
time frame: Calculated using concentration data collected from predose to 16 hours postdose on Day 17 in Part 3
description: t1/2: apparent terminal half-life
measure: Part 3. Number of total AEs and number of subjects with AEs during the treatment period
time frame: From Day 1 (first dose) to Day 19 (end of treatment period) in Part 3
description: AEs: adverse events
measure: Part 3. Number of subjects with systolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)
description: Normal: ≥90 and ≤140 mmHg. Clinical significance of abnormal values as judged by the investigator
measure: Part 3. Number of subjects with diastolic blood pressure in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)
description: Normal: ≥45 and ≤90 mmHg. Clinical significance of abnormal values as judged by the investigator
measure: Part 3. Number of subjects with pulse rate in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)
description: Normal: ≥40 and ≤100 beats/minute. Clinical significance of abnormal values as judged by the investigator
measure: Part 3. Number of subjects with body temperature in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Days 1, 3, 5, 7, 9, and 11: predose and 4 hours postdose; Day 17: predose, 4 hours, and 12 hours postdose; Day 19 (=48 hours postdose)
description: Normal: ≥35 and ≤37.5°C. Clinical significance of abnormal values as judged by the investigator
measure: Part 3. Number of subjects with PR interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)
description: Normal: ≥120 and ≤220 msec. Clinical significance of abnormal values as judged by the investigator
measure: Part 3. Number of subjects with QRS duration in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)
description: Normal: ≤120 msec. Clinical significance of abnormal values as judged by the investigator
measure: Part 3. Number of subjects with QTcF interval in each of the following categories: 'normal', 'abnormal, not clinically significant', 'abnormal, clinically significant'
time frame: At screening and during the treatment period in Part 3: Day 1: predose and 4 hours postdose; Days 3, 5, 7, 9, 11, and 17: 4 hours postdose; Day 19 (=48 hours postdose)
description: QTcF: QT interval corrected for heart rate according to Fridericia's method. Normal: ≤450 msec for males and ≤470 msec for females. Clinical significance of abnormal values as judged by the investigator
arm group label: Group 1-1
arm group type: Active Comparator
description: Part 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation/treatment period): LEO 32731 modified release tablet; LEO 32731 blend, hard capsule; LEO 32731 API hard capsule (reference formulation).
arm group label: Group 1-2
arm group type: Active Comparator
description: Part 1: Subjects will receive 3 doses of LEO 32731 in different formulations, as follows (1 dose per formulation/treatment period): LEO 32731 soft capsule; LEO 32731 gastro-resistant capsule; LEO 32731 API hard capsule (reference formulation).
arm group label: Group 2-1
arm group type: Experimental
description: Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast.
The formulation depends on the outcome of Part 1.
arm group label: Group 2-2
arm group type: Experimental
description: Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast.
The formulation depends on the outcome of Part 1.
arm group label: Group 2-3
arm group type: Experimental
description: Part 2: Subjects will receive 3 doses of the same LEO 32731 formulation under different conditions, as follow (1 dose per condition/treatment period): fasted, after low-fat breakfast, after high-fat breakfast.
The formulation depends on the outcome of Part 1.
arm group label: Group 3-1
arm group type: Placebo Comparator
description: Subjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.
arm group label: Group 3-2
arm group type: Placebo Comparator
description: Subjects will be dosed twice daily from Days 1-17 (morning dose only on Day 17) with LEO 32731 or placebo. The formulation depends on the outcome of Part 2.
intervention type: Drug
intervention name: LEO 32731 modified release tablet
description: At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.
arm group label: Group 1-1
intervention type: Drug
intervention name: LEO 32731 blend, hard capsule
description: At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
arm group label: Group 1-1
intervention type: Drug
intervention name: LEO 32731 API, hard capsule
description: At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
arm group label: Group 1-1
arm group label: Group 1-2
intervention type: Drug
intervention name: LEO 32731 soft capsule
description: At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
arm group label: Group 1-2
intervention type: Drug
intervention name: LEO 32731 gastro-resistant capsule
description: At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
arm group label: Group 1-2
intervention type: Drug
intervention name: LEO 32731
description: At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.
arm group label: Group 2-1
arm group label: Group 2-2
arm group label: Group 2-3
arm group label: Group 3-1
arm group label: Group 3-2
intervention type: Other
intervention name: Placebo
description: At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.
arm group label: Group 3-1
arm group label: Group 3-2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Expert
role: Study Director
affiliation: LEO Pharma
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: External researchers with no commercial interest who provide scientifically sound research proposal
ipd url: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx