<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/NCT02209766</url>
  </required_header>
  <id_info>
    <org_study_id>D5881C00005</org_study_id>
    <nct_id>NCT02209766</nct_id>
  </id_info>
  <brief_title>A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)</brief_title>
  <official_title>A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884&#xD;
      following administration of single and multiple doses in healthy male Japanese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study&#xD;
      Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese&#xD;
      subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel&#xD;
      studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in a&#xD;
      single and multiple dose open-label study.&#xD;
&#xD;
      Two dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up&#xD;
      to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2&#xD;
      cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in&#xD;
      a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.&#xD;
&#xD;
      Following a screening period of a maximum of 42 days, subjects will reside at the study&#xD;
      facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of&#xD;
      discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose&#xD;
      administration in all 3 study arms will be done in the following sequence: a single dose of&#xD;
      D5884 or placebo will be administered; this will be followed by a 2-day washout period; after&#xD;
      the washout period, multiple doses of D5884 or placebo will be administered, once daily for&#xD;
      14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or placebo&#xD;
      (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3) and the 3rd&#xD;
      cohort (Study Arm C) will receive 4 g D5884 (n=6).&#xD;
&#xD;
      The PK analysis included all evaluable PK data appropriate for the evaluation of interest&#xD;
      (eg, with no major protocol deviations or violations thought to significantly affect the PK&#xD;
      of the drug) from all subjects who received D5884.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)</measure>
    <time_frame>from first dosing (Day1) until follow-up (Day25)</time_frame>
    <description>Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax in Plasma Baseline-adjusted Total EPA, Single Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax in Plasma Baseline-adjusted Total DHA, Single Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose</measure>
    <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>D5884</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D5884 capsule, Per oral(po)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule, po</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D5884</intervention_name>
    <description>1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian</description>
    <arm_group_label>D5884</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>st cohort: Dose 1(2g) D5884(n=3) in Japanese&#xD;
nd cohort: Dose 2(4g) D5884(n=3) in Japanese</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult male, 20 to 45 years of age (inclusive)&#xD;
&#xD;
          2. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 for Japanese subjects, ≥18.5 and ≤30 kg/m2&#xD;
             for Caucasian subjects. BMI calculations to be conducted on height and weight values&#xD;
             obtained at Visit 1&#xD;
&#xD;
          3. Medically healthy with clinically insignificant screening results (eg, laboratory&#xD;
             profile, medical history, ECGs, physical examination). Haemoglobin has to be ≥ the&#xD;
             lower limit of the study site reference range, 12-lead ECG must have QT interval&#xD;
             corrected for heart rate using Fridericia's formula(QTcF) &gt;340 msec and &lt;450 msec&#xD;
&#xD;
          4. No habitual use of drug(s) and non-tobacco/nicotine-containing products for a minimum&#xD;
             of 6 months prior to dosing&#xD;
&#xD;
          5. Subjects must be willing and able to give written informed consent by signing an&#xD;
             Institutional Review Board(IRB)-approved informed consent form (ICF) prior to&#xD;
             admission to this study and follow the restrictions and procedures outlined for the&#xD;
             study.&#xD;
&#xD;
          6. Mean fasting Triglyceride(TG) at -4 and -2 weeks of &lt;150 mg/dL, and %TG change of &lt;30%&#xD;
             between Weeks -4 and -2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in another clinical study with an investigational product(IP) during the&#xD;
             4 months prior to enrolment&#xD;
&#xD;
          2. Past history of psychological or physical disorder which may affect the objectives of&#xD;
             this study, in the opinion of the PI&#xD;
&#xD;
          3. An individual who has abnormal laboratory values (ie, suggesting hepatic, renal,&#xD;
             cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate&#xD;
             current or past medical history for participation based on the decision of the&#xD;
             principal investigator(PI)&#xD;
&#xD;
          4. A history or presence of significant cardiovascular, pulmonary, hepatic, renal,&#xD;
             haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or&#xD;
             psychiatric disease&#xD;
&#xD;
          5. A positive urine drug/alcohol test at screening or admission (Visit 3, Day -1). (The&#xD;
             drug test includes testing for phencyclidine, benzodiazepine, cocaine, amphetamines,&#xD;
             cannabis, opiates, barbiturates and tricyclic anti-depressants. The alcohol test is an&#xD;
             alcohol breath assessment.)&#xD;
&#xD;
          6. A positive test for syphilis, human immunodeficiency virus, hepatitis B surface&#xD;
             antigen or hepatitis C virus antibodies.&#xD;
&#xD;
          7. Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months of the&#xD;
             planned time of admission&#xD;
&#xD;
          8. Current evidence, or a history of alcoholism or drug abuse within the 2 years prior to&#xD;
             admission&#xD;
&#xD;
          9. A known sensitivity or allergy to soybeans, fish and/or shellfish&#xD;
&#xD;
         10. A hypersensitivity or idiosyncratic reaction to compounds related to EPA and/or DHA&#xD;
&#xD;
         11. Had used any prescription medication within 14 days prior to admission&#xD;
&#xD;
         12. Had used any over-the-counter (OTC) medication, including herbal products (bromelains,&#xD;
             danshen, dong quai [Angelica sinensis], garlic, ginko biloba, ginseng, and St. John's&#xD;
             wort), within the 7 days prior to admission&#xD;
&#xD;
         13. Had used any drugs known to significantly inhibit [strong or moderate] or induce liver&#xD;
             enzymes involved in drug metabolism [cytochrome P450]) within 30 days prior to&#xD;
             admission&#xD;
&#xD;
         14. Had donated blood or had had significant blood loss in excess of 200 mL within 1 month&#xD;
             prior to admission or in excess of 400 mL within 3 months prior to admission&#xD;
&#xD;
         15. Had donated plasma within 7 days prior to admission&#xD;
&#xD;
         16. History of drug abuse or past history of alcohol abuse or habit of taking&#xD;
             nicotine-containing product(s) on a daily basis&#xD;
&#xD;
         17. Those who have difficulty in giving blood during blood sampling via the peripheral&#xD;
             vein&#xD;
&#xD;
         18. Any potential subjects who are considered as not eligible for the study in the opinion&#xD;
             of the PI and/or the sub-investigator&#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>Hiroyuki Fukase, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CPC Clinical Trial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CPC Clinical Trial Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>8900081</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>October 30, 2015</results_first_submitted>
  <results_first_submitted_qc>April 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 17, 2016</results_first_posted>
  <last_update_submitted>April 11, 2016</last_update_submitted>
  <last_update_submitted_qc>April 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>D5884</keyword>
  <keyword>Japanese</keyword>
  <keyword>Caucasian</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>86 male subjects were screened.</recruitment_details>
      <pre_assignment_details>Of the 86 subjects, 43 did not meet the inclusion/exclusion criteria, 14 decided not to participate in the study and 5 had other reasons for declining participation in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>2 g D5884 Japanese</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="P2">
          <title>2 g D5884 Japanese Placebo</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="P3">
          <title>4 g D5884 Japanese</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="P4">
          <title>4g D5844 Japanese Placebo</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="P5">
          <title>4g D5884 Caucasian</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized subjects</population>
      <group_list>
        <group group_id="B1">
          <title>2 g D5884 Japanese</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="B2">
          <title>4 g D5884 Japanese</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="B3">
          <title>4 g D5884 Caucasian</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="B4">
          <title>Placebo Japanese</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.7" spread="8.71"/>
                    <measurement group_id="B2" value="28.3" spread="6.15"/>
                    <measurement group_id="B3" value="34.0" spread="5.25"/>
                    <measurement group_id="B4" value="32.3" spread="6.12"/>
                    <measurement group_id="B5" value="30.3" spread="6.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.42" spread="8.109"/>
                    <measurement group_id="B2" value="69.08" spread="7.059"/>
                    <measurement group_id="B3" value="72.92" spread="10.169"/>
                    <measurement group_id="B4" value="62.63" spread="6.371"/>
                    <measurement group_id="B5" value="66.26" spread="9.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.67" spread="0.852"/>
                    <measurement group_id="B2" value="22.67" spread="1.517"/>
                    <measurement group_id="B3" value="22.55" spread="1.724"/>
                    <measurement group_id="B4" value="21.40" spread="1.370"/>
                    <measurement group_id="B5" value="21.82" spread="1.559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose</title>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.22" spread="45.10"/>
                    <measurement group_id="O2" value="220.0" spread="17.70"/>
                    <measurement group_id="O3" value="158.1" spread="34.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax in Plasma Baseline-adjusted Total EPA, Single Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax in Plasma Baseline-adjusted Total EPA, Single Dose</title>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.50" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="5.00" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O3" value="6.00" lower_limit="5.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose</title>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.04" spread="69.51"/>
                    <measurement group_id="O2" value="90.10" spread="21.50"/>
                    <measurement group_id="O3" value="63.63" spread="46.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax in Plasma Baseline-adjusted Total DHA, Single Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax in Plasma Baseline-adjusted Total DHA, Single Dose</title>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="4.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="5.00" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O3" value="5.00" lower_limit="5.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose</title>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.4" spread="32.73"/>
                    <measurement group_id="O2" value="314.8" spread="26.09"/>
                    <measurement group_id="O3" value="238.8" spread="33.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose</title>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="5.50" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O3" value="5.00" lower_limit="5.00" upper_limit="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose</title>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.47" spread="49.15"/>
                    <measurement group_id="O2" value="88.21" spread="89.54"/>
                    <measurement group_id="O3" value="101.1" spread="34.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose</title>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="6.00" lower_limit="5.00" upper_limit="6.00"/>
                    <measurement group_id="O3" value="5.00" lower_limit="5.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)</title>
        <description>Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)</description>
        <time_frame>from first dosing (Day1) until follow-up (Day25)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O4">
            <title>Placebo Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)</title>
          <description>Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)</description>
          <units>subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to discontinued</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose</title>
          <units>μg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="531.2" spread="75.81"/>
                    <measurement group_id="O2" value="621.9" spread="278.9"/>
                    <measurement group_id="O3" value="1044" spread="48.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose</title>
          <units>μg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2072" spread="39.29"/>
                    <measurement group_id="O2" value="4067" spread="43.52"/>
                    <measurement group_id="O3" value="3136" spread="28.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose</title>
          <units>μg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.2" spread="80.07"/>
                    <measurement group_id="O2" value="432.9" spread="39.97"/>
                    <measurement group_id="O3" value="783.2" spread="78.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose</title>
        <time_frame>Day1-3, 4, 7, 11, 14, 17-18 and 25</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O2">
            <title>4g D5884 Japanese</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
          <group group_id="O3">
            <title>4g D5885 Caucasian</title>
            <description>Single dose followed by once daily for 14 consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose</title>
          <units>μg*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1108" spread="38.37"/>
                    <measurement group_id="O2" value="2213" spread="31.67"/>
                    <measurement group_id="O3" value="2105" spread="25.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>2 g D4884 Japanese</title>
        </group>
        <group group_id="E2">
          <title>4 g D4884 Japanese</title>
        </group>
        <group group_id="E3">
          <title>4 g D4884 Caucasian</title>
        </group>
        <group group_id="E4">
          <title>Placebo Japanese</title>
          <description>Single dose followed by once daily for 14 consecutive days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.166</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALT increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>AST increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hideo Negi</name_or_title>
      <organization>CO RIA TA, R&amp;D</organization>
      <phone>+81 6 4803 3533 ext 4716</phone>
      <email>H.Negi@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02209766
org study id: D5881C00005
nct id: NCT02209766
lead sponsor: 
has dmc: No
The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884
      following administration of single and multiple doses in healthy male Japanese subjects.
This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study
      Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese
      subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel
      studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in a
      single and multiple dose open-label study.

      Two dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up
      to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2
      cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in
      a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.

      Following a screening period of a maximum of 42 days, subjects will reside at the study
      facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of
      discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose
      administration in all 3 study arms will be done in the following sequence: a single dose of
      D5884 or placebo will be administered; this will be followed by a 2-day washout period; after
      the washout period, multiple doses of D5884 or placebo will be administered, once daily for
      14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or placebo
      (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3) and the 3rd
      cohort (Study Arm C) will receive 4 g D5884 (n=6).

      The PK analysis included all evaluable PK data appropriate for the evaluation of interest
      (eg, with no major protocol deviations or violations thought to significantly affect the PK
      of the drug) from all subjects who received D5884.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)
time frame: from first dosing (Day1) until follow-up (Day25)
description: Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)
measure: Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Tmax in Plasma Baseline-adjusted Total EPA, Single Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Tmax in Plasma Baseline-adjusted Total DHA, Single Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
measure: AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose
time frame: Day1-3, 4, 7, 11, 14, 17-18 and 25
arm group label: D5884
arm group type: Experimental
description: D5884 capsule, Per oral(po)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule, po
intervention type: Drug
intervention name: D5884
description: 1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian
arm group label: D5884
intervention type: Drug
intervention name: Placebo
description: st cohort: Dose 1(2g) D5884(n=3) in Japanese
nd cohort: Dose 2(4g) D5884(n=3) in Japanese
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hiroyuki Fukase, MD
role: Principal Investigator
affiliation: CPC Clinical Trial Hospital
facility: 
country: Japan
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 