<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/NCT02248818</url>
  </required_header>
  <id_info>
    <org_study_id>D5800C00001</org_study_id>
    <nct_id>NCT02248818</nct_id>
  </id_info>
  <brief_title>AZD8108 SAD/MAD in Healthy Volunteers</brief_title>
  <acronym>AZD8108</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AZD8108 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled study of single and multiple ascending&#xD;
      dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening&#xD;
      period, an in-house period during which AZD8108 or placebo will be administered orally as a&#xD;
      solution, and a 4- to 10-day follow-up period after discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be&#xD;
      randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts&#xD;
      (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108&#xD;
      and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose&#xD;
      of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose&#xD;
      portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be&#xD;
      randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be&#xD;
      randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each&#xD;
      subject will receive twelve doses of either AZD8108 or placebo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal</measure>
    <time_frame>Day -1 to 7 days after last dose</time_frame>
    <description>Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108</measure>
    <time_frame>Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose</time_frame>
    <description>Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose</time_frame>
    <description>Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 &amp; 7, Cohort 6 did not reach Day 6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose</time_frame>
    <description>Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 &amp; 7, Cohort 6 did not reach Day 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose</time_frame>
    <description>Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 &amp; 7, Cohort 6 dod not reach Day 12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose</time_frame>
    <description>Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose</time_frame>
    <description>Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 &amp; 7, Cohort 6 did not reach Day 6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose</time_frame>
    <description>Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 &amp; 7, Cohort 6 did not reach Day 12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose</time_frame>
    <description>Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108</measure>
    <time_frame>Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose</time_frame>
    <description>Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108</measure>
    <time_frame>Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose</time_frame>
    <description>Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 &amp; 7, Cohort 6 did not reach day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108</measure>
    <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose</time_frame>
    <description>Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 &amp; 7, Cohort 6 did not reach day 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD</measure>
    <time_frame>Day 12 compared to Day 1</time_frame>
    <description>Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 &amp; 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]</description>
  </secondary_outcome>
  <other_outcome>
    <measure>EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction</measure>
    <time_frame>8 hours after dose</time_frame>
    <description>EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest</description>
  </other_outcome>
  <other_outcome>
    <measure>EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction</measure>
    <time_frame>8 hours after dose</time_frame>
    <description>EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 &amp; 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest</description>
  </other_outcome>
  <other_outcome>
    <measure>EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction</measure>
    <time_frame>8 hours after dose</time_frame>
    <description>EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 &amp; 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>AZD8108</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to match AZD8108</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD8108</intervention_name>
    <description>Drug: AZD8108 Single or Multiple doses administered orally as a solution.</description>
    <arm_group_label>AZD8108</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution</description>
    <arm_group_label>Placebo to match AZD8108</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the study&#xD;
        and must provide signed and dated written informed consent in accordance with local&#xD;
        regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal&#xD;
        or surgically sterile women age 18-55 years inclusive. 3. Subjects must have a body mass&#xD;
        index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.&#xD;
        4.Subjects must be fluent in English.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:1. A history or presence of a clinically significant hepatic, renal,&#xD;
        gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic,&#xD;
        dermatologic, or neurologic abnormality. 2. A clinically significant abnormality on&#xD;
        physical examination, neurological examination, EEG, ECG, vital signs or laboratory&#xD;
        evaluations at screen or between screen and dose administration. 3. A history of seizure.&#xD;
        4.A history of head trauma, including closed head injury with loss of consciousness. 5.Any&#xD;
        history of suicide attempt or suicidal behavior, or, in the opinion of the investigator,&#xD;
        clinically significant risk of suicide or violent behavior. 6. Urine drug screen positive&#xD;
        for a drug of abuse 7. A family history of schizophrenia, schizoaffective disorder, or&#xD;
        psychosis in first degree relatives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mina Pastagia, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinilabs, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinilabs, Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>August 17, 2016</results_first_submitted>
  <results_first_submitted_qc>December 5, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 27, 2017</results_first_posted>
  <last_update_submitted>March 9, 2017</last_update_submitted>
  <last_update_submitted_qc>March 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy Adult volunteer study, Part 1: SAD: single ascending dose cohorts, followed by Part 2: MAD: multiple ascending dose cohorts. Plan was for each cohort to have 8 subjects, 2 placebo dosed and 6 AZD8108 dosed.</recruitment_details>
      <pre_assignment_details>Protocol allowed for 258 subjects to be screened, only 155 subjects were screened before all cohorts for the study were filled and recruitment ended.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AZD8108 20 mg SAD</title>
          <description>AZD8108 20 mg SAD, Cohort 1</description>
        </group>
        <group group_id="P2">
          <title>AZD8108 60 mg SAD</title>
          <description>AZD8106 60 mg SAD, Cohort 2</description>
        </group>
        <group group_id="P3">
          <title>AZD8108 95 mg SAD</title>
          <description>AZD8108 95 mg SAD, Cohort 3</description>
        </group>
        <group group_id="P4">
          <title>Placebo SAD</title>
          <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
        </group>
        <group group_id="P5">
          <title>AZD8108 50 mg</title>
          <description>AZD8108 50 mg MAD, Cohort 5</description>
        </group>
        <group group_id="P6">
          <title>AZD8108 90 mg MAD (6)</title>
          <description>AZD8108 90 mg MAD, Cohort 6</description>
        </group>
        <group group_id="P7">
          <title>AZD8108 90 mg MAD (7)</title>
          <description>AZD8108 90 mg MAD, Cohort 7</description>
        </group>
        <group group_id="P8">
          <title>Placebo MAD</title>
          <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
        </group>
        <group group_id="P9">
          <title>Screen</title>
          <description>Screen - no treatment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Screening</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="48"/>
              </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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="107"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study fully enrolled</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="73"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Randomised Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="0"/>
              </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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Administrative - randomization error</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AZD8108 20 mg - SAD</title>
          <description>AZD8108 20 mg SAD, Cohort 1</description>
        </group>
        <group group_id="B2">
          <title>AZD8108 60 mg - SAD</title>
          <description>AZD8108 60 mg SAD, Cohort 2</description>
        </group>
        <group group_id="B3">
          <title>AZD8108 95 mg - SAD</title>
          <description>AZD8108 95 mg SAD, Cohort 3</description>
        </group>
        <group group_id="B4">
          <title>Placebo SAD</title>
          <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
        </group>
        <group group_id="B5">
          <title>AZD8108 50 mg MAD</title>
          <description>AZD8108 50 mg MAD, Cohort 5</description>
        </group>
        <group group_id="B6">
          <title>AZD8108 90 mg MAD (6)</title>
          <description>AZD8108 90 mg MAD, Cohort 6</description>
        </group>
        <group group_id="B7">
          <title>AZD8108 90 mg MAD (7)</title>
          <description>AZD8108 90 mg MAD, Cohort 7</description>
        </group>
        <group group_id="B8">
          <title>Placebo MAD</title>
          <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
        </group>
        <group group_id="B9">
          <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="6"/>
            <count group_id="B6" value="8"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="4"/>
            <count group_id="B9" value="48"/>
          </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="36.0" spread="10.81"/>
                    <measurement group_id="B2" value="36.3" spread="12.55"/>
                    <measurement group_id="B3" value="38.7" spread="10.53"/>
                    <measurement group_id="B4" value="38.0" spread="10.53"/>
                    <measurement group_id="B5" value="36.7" spread="7.89"/>
                    <measurement group_id="B6" value="35.4" spread="10.31"/>
                    <measurement group_id="B7" value="31.2" spread="2.64"/>
                    <measurement group_id="B8" value="39.3" spread="9.22"/>
                    <measurement group_id="B9" value="36.0" spread="9.62"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal</title>
        <description>Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal</description>
        <time_frame>Day -1 to 7 days after last dose</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal</title>
          <description>Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal</description>
          <population>Safety population</population>
          <units>Participants</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 group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108</title>
        <description>Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108</description>
        <time_frame>Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108</title>
          <description>Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
          <units>hours*ng/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 group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="726" spread="22.4"/>
                    <measurement group_id="O2" value="2651" spread="17.1"/>
                    <measurement group_id="O3" value="4533" spread="11.3"/>
                    <measurement group_id="O5" value="2160" spread="37.8"/>
                    <measurement group_id="O6" value="4318" spread="13.2"/>
                    <measurement group_id="O7" value="4597" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108</title>
        <description>Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 &amp; 7, Cohort 6 did not reach Day 6</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108</title>
          <description>Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 &amp; 7, Cohort 6 did not reach Day 6</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
          <units>hours*ng/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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="2061" spread="34.7"/>
                    <measurement group_id="O7" value="4408" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108</title>
        <description>Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 &amp; 7, Cohort 6 did not reach Day 12</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108</title>
          <description>Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 &amp; 7, Cohort 6 did not reach Day 12</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
          <units>hours*ng/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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="2837" spread="47.6"/>
                    <measurement group_id="O7" value="6733" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108</title>
        <description>Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 &amp; 7, Cohort 6 dod not reach Day 12</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108</title>
          <description>Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 &amp; 7, Cohort 6 dod not reach Day 12</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
          <units>hours*ng/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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="2191" spread="38.1"/>
                    <measurement group_id="O7" value="4670" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108</title>
        <description>Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108</title>
          <description>Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108)</population>
          <units>ng/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 group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.1" spread="22.4"/>
                    <measurement group_id="O2" value="148" spread="19.3"/>
                    <measurement group_id="O3" value="264" spread="17.8"/>
                    <measurement group_id="O5" value="146" spread="27.5"/>
                    <measurement group_id="O6" value="287" spread="22.7"/>
                    <measurement group_id="O7" value="236" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108</title>
        <description>Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 &amp; 7, Cohort 6 did not reach Day 6</description>
        <time_frame>Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 &amp; 7</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108</title>
          <description>Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 &amp; 7, Cohort 6 did not reach Day 6</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 &amp; 7</population>
          <units>ng/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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="176" spread="23.9"/>
                    <measurement group_id="O7" value="330" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108</title>
        <description>Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 &amp; 7, Cohort 6 did not reach Day 12</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose</time_frame>
        <population>Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 &amp; 7</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108</title>
          <description>Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 &amp; 7, Cohort 6 did not reach Day 12</description>
          <population>Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 &amp; 7</population>
          <units>ng/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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="197" spread="30.4"/>
                    <measurement group_id="O7" value="337" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108</title>
        <description>Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose</time_frame>
        <population>Pharmacokinetic population (subjects dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108</title>
          <description>Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108</description>
          <population>Pharmacokinetic population (subjects dosed with AZD8108)</population>
          <units>hours</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 group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" lower_limit="1.00" upper_limit="3.03"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O3" value="2.50" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O5" value="1.25" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O6" value="1.28" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O7" value="2.55" lower_limit="1.52" upper_limit="10.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108</title>
        <description>Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)</description>
        <time_frame>Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose</time_frame>
        <population>Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108</title>
          <description>Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)</description>
          <population>Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed</population>
          <units>Percent</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants with urine volume data</units_analyzed>
          <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="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Participants with urine volume data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8" spread="55.2"/>
                    <measurement group_id="O2" value="33.8" spread="30.1"/>
                    <measurement group_id="O3" value="38.8" spread="8.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108</title>
        <description>Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 &amp; 7, Cohort 6 did not reach day 12</description>
        <time_frame>Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose</time_frame>
        <population>Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108</title>
          <description>Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 &amp; 7, Cohort 6 did not reach day 12</description>
          <population>Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed</population>
          <units>Percent</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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="49.4" spread="28.1"/>
                    <measurement group_id="O7" value="30.2" spread="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108</title>
        <description>Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 &amp; 7, Cohort 6 did not reach day 12</description>
        <time_frame>Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose</time_frame>
        <population>Pharmacokinetic population (subjects dosed with AZD8108)</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108</title>
          <description>Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 &amp; 7, Cohort 6 did not reach day 12</description>
          <population>Pharmacokinetic population (subjects dosed with AZD8108)</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1.75" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O7" value="1.80" lower_limit="1.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD</title>
        <description>Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 &amp; 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]</description>
        <time_frame>Day 12 compared to Day 1</time_frame>
        <population>Pharmacokinetic population, MAD Cohorts 5 &amp; 7</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD</title>
          <description>Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 &amp; 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]</description>
          <population>Pharmacokinetic population, MAD Cohorts 5 &amp; 7</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1.30" spread="0.181"/>
                    <measurement group_id="O7" value="1.37" spread="0.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1.39" spread="0.254"/>
                    <measurement group_id="O7" value="1.44" spread="0.165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction</title>
        <description>EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest</description>
        <time_frame>8 hours after dose</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction</title>
          <description>EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest</description>
          <population>Safety population</population>
          <units>uV2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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 group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0.5 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.069" spread="0.3715"/>
                    <measurement group_id="O2" value="-0.272" spread="0.2422"/>
                    <measurement group_id="O3" value="-0.166" spread="0.1880"/>
                    <measurement group_id="O4" value=".0141" spread="0.2358"/>
                    <measurement group_id="O5" value="-0.343" spread="0.3348"/>
                    <measurement group_id="O6" value="0.087" spread="0.3979"/>
                    <measurement group_id="O7" value="-0.154" spread="0.2555"/>
                    <measurement group_id="O8" value="0.128" spread="0.5069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.101" spread="0.2638"/>
                    <measurement group_id="O2" value="-0.238" spread="0.4504"/>
                    <measurement group_id="O3" value="-0.140" spread="0.2520"/>
                    <measurement group_id="O4" value="-0.003" spread="0.1467"/>
                    <measurement group_id="O5" value="-0.109" spread="0.5843"/>
                    <measurement group_id="O6" value="0.092" spread="0.3466"/>
                    <measurement group_id="O7" value="-0.063" spread="0.2291"/>
                    <measurement group_id="O8" value="-0.121" spread="0.2005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.113" spread="0.2616"/>
                    <measurement group_id="O2" value="-0.161" spread="0.6017"/>
                    <measurement group_id="O3" value="-0.069" spread="0.2095"/>
                    <measurement group_id="O4" value="0.097" spread="0.3402"/>
                    <measurement group_id="O5" value="0.211" spread="0.5514"/>
                    <measurement group_id="O6" value="-0.052" spread="0.3888"/>
                    <measurement group_id="O7" value="0.016" spread="0.3687"/>
                    <measurement group_id="O8" value="0.313" spread="0.2701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.244" spread="0.2577"/>
                    <measurement group_id="O2" value="-0.347" spread="0.3231"/>
                    <measurement group_id="O3" value="-0.080" spread="0.2324"/>
                    <measurement group_id="O4" value="-0.086" spread="0.2350"/>
                    <measurement group_id="O5" value="-0.303" spread="0.4675"/>
                    <measurement group_id="O6" value="-0.142" spread="0.2639"/>
                    <measurement group_id="O7" value="-0.097" spread="0.2185"/>
                    <measurement group_id="O8" value="0.019" spread="0.2661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.214" spread="0.2120"/>
                    <measurement group_id="O2" value="-0.254" spread="0.2461"/>
                    <measurement group_id="O3" value="-0.108" spread="0.1569"/>
                    <measurement group_id="O4" value="0.126" spread="0.1181"/>
                    <measurement group_id="O5" value="-0.369" spread="0.4360"/>
                    <measurement group_id="O6" value="0.058" spread="0.4186"/>
                    <measurement group_id="O7" value="0.011" spread="0.3292"/>
                    <measurement group_id="O8" value="0.247" spread="0.4936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.225" spread="0.1615"/>
                    <measurement group_id="O2" value="-0.454" spread="0.2641"/>
                    <measurement group_id="O3" value="-0.014" spread="0.1025"/>
                    <measurement group_id="O4" value="0.138" spread="0.3071"/>
                    <measurement group_id="O5" value="-0.514" spread="0.4117"/>
                    <measurement group_id="O6" value="-0.073" spread="0.3506"/>
                    <measurement group_id="O7" value="-0.25" spread="0.2971"/>
                    <measurement group_id="O8" value="-0.151" spread="0.2954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.222" spread="0.5150"/>
                    <measurement group_id="O2" value="-0.263" spread="0.1219"/>
                    <measurement group_id="O3" value="-0.086" spread="0.3075"/>
                    <measurement group_id="O4" value="0.091" spread="0.4193"/>
                    <measurement group_id="O5" value="-0.125" spread="0.4958"/>
                    <measurement group_id="O6" value="-0.169" spread="0.3217"/>
                    <measurement group_id="O7" value="-0.124" spread="0.3209"/>
                    <measurement group_id="O8" value="0.034" spread="0.3623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction</title>
        <description>EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 &amp; 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest</description>
        <time_frame>8 hours after dose</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction</title>
          <description>EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 &amp; 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest</description>
          <population>Safety population</population>
          <units>uV2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose Day 6 dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.167" spread="0.3959"/>
                    <measurement group_id="O7" value="0.080" spread="0.4827"/>
                    <measurement group_id="O8" value="0.128" spread="0.3311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.5 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.514" spread="0.3729"/>
                    <measurement group_id="O7" value="0.131" spread="0.3518"/>
                    <measurement group_id="O8" value="0.384" spread="0.7434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.322" spread="0.6343"/>
                    <measurement group_id="O7" value="0.063" spread="0.2129"/>
                    <measurement group_id="O8" value="-0.123" spread="0.3713"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.353" spread="0.2722"/>
                    <measurement group_id="O7" value="0.109" spread="0.0729"/>
                    <measurement group_id="O8" value="0.375" spread="0.5060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.460" spread="0.2219"/>
                    <measurement group_id="O7" value="0.279" spread="0.5172"/>
                    <measurement group_id="O8" value="0.223" spread="0.3813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.263" spread="0.4014"/>
                    <measurement group_id="O7" value="0.016" spread="0.1550"/>
                    <measurement group_id="O8" value="0.435" spread="0.3796"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.350" spread="0.7782"/>
                    <measurement group_id="O7" value="0.031" spread="0.2103"/>
                    <measurement group_id="O8" value="-0.018" spread="0.6197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours after dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.454" spread="0.4568"/>
                    <measurement group_id="O7" value="-0.028" spread="0.3062"/>
                    <measurement group_id="O8" value="0.271" spread="0.3849"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction</title>
        <description>EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 &amp; 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest</description>
        <time_frame>8 hours after dose</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8108 20 mg SAD</title>
            <description>AZD8108 20 mg SAD, Cohort 1</description>
          </group>
          <group group_id="O2">
            <title>AZD8108 60 mg SAD</title>
            <description>AZD8106 60 mg SAD, Cohort 2</description>
          </group>
          <group group_id="O3">
            <title>AZD8108 95 mg SAD</title>
            <description>AZD8108 95 mg SAD, Cohort 3</description>
          </group>
          <group group_id="O4">
            <title>Placebo SAD</title>
            <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
          </group>
          <group group_id="O5">
            <title>AZD8108 50 mg MAD</title>
            <description>AZD8108 50 mg MAD, Cohort 5</description>
          </group>
          <group group_id="O6">
            <title>AZD8108 90 mg MAD (6)</title>
            <description>AZD8108 90 mg MAD, Cohort 6</description>
          </group>
          <group group_id="O7">
            <title>AZD8108 90 mg MAD (7)</title>
            <description>AZD8108 90 mg MAD, Cohort 7</description>
          </group>
          <group group_id="O8">
            <title>Placebo MAD</title>
            <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</description>
          </group>
        </group_list>
        <measure>
          <title>EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction</title>
          <description>EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 &amp; 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest</description>
          <population>Safety population</population>
          <units>uV2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre dose Day 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.075" spread="0.5040"/>
                    <measurement group_id="O7" value="-0.065" spread="0.1789"/>
                    <measurement group_id="O8" value="0.015" spread="0.1749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.5 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.309" spread="0.7025"/>
                    <measurement group_id="O7" value="-0.134" spread="0.2459"/>
                    <measurement group_id="O8" value="0.334" spread="0.3440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.193" spread="1.4967"/>
                    <measurement group_id="O7" value="-0.107" spread="0.1970"/>
                    <measurement group_id="O8" value="0.253" spread="0.3448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.073" spread="0.9299"/>
                    <measurement group_id="O7" value="-0.062" spread="0.1783"/>
                    <measurement group_id="O8" value="0.373" spread="0.3358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.207" spread="0.6381"/>
                    <measurement group_id="O7" value="-0.087" spread="0.3025"/>
                    <measurement group_id="O8" value="-0.046" spread="0.2830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.119" spread="0.6208"/>
                    <measurement group_id="O7" value="-0.024" spread="0.2590"/>
                    <measurement group_id="O8" value="0.234" spread="0.3109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="-0.506" spread="0.4329"/>
                    <measurement group_id="O7" value="0.040" spread="0.1775"/>
                    <measurement group_id="O8" value="0.090" spread="0.4258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.022" spread="1.0703"/>
                    <measurement group_id="O7" value="-0.048" spread="0.0975"/>
                    <measurement group_id="O8" value="0.178" spread="0.2510"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SAD cohorts 2 weeks, MAD cohorts up to 1 month</time_frame>
      <desc>From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>AZD8108 20 mg SAD</title>
          <description>AZD8108 20 mg SAD, Cohort 1</description>
        </group>
        <group group_id="E2">
          <title>AZD8108 60 mg SAD</title>
          <description>AZD8106 60 mg SAD, Cohort 2</description>
        </group>
        <group group_id="E3">
          <title>AZD8108 95 mg SAD</title>
          <description>AZD8108 95 mg SAD, Cohort 3</description>
        </group>
        <group group_id="E4">
          <title>Placebo SAD</title>
          <description>Placebo SAD, pooled across Cohorts 1 - 3</description>
        </group>
        <group group_id="E5">
          <title>AZD8108 50 mg MAD</title>
          <description>AZD8108 50 mg MAD, Cohort 5</description>
        </group>
        <group group_id="E6">
          <title>AZD8108 90 mg MAD (6)</title>
          <description>AZD8108 90 mg MAD, Cohort 6</description>
        </group>
        <group group_id="E7">
          <title>AZD8108 90 mg MAD (7)</title>
          <description>AZD8108 90 mg MAD, Cohort 7</description>
        </group>
        <group group_id="E8">
          <title>Placebo MAD</title>
          <description>Placebo MAD, pooled across Cohorts 5 &amp; 7</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"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA version 17.1</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="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rash pustular</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle Twitching</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"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysguesia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" 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="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nystagmus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dizziness</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Headache</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Sensory disturbance</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Euphoric mood</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="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Halucination, visual</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"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Irritability</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"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dysphoria</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Initial insomnia</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nightmare</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis acneiform</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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Conversion of AZD8108 to active moiety AZD6567 was rapid, concentrations of AZD8108 were almost all below the level of quantification, no PK parameters were calculable for AZD8108 concentrations.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Joel Posner MD</name_or_title>
      <organization>AstraZeneca LP</organization>
      <email>ClinicalTrialTransparency@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/NCT02248818
org study id: D5800C00001
nct id: NCT02248818
lead sponsor: 
has dmc: Yes
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending
      dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening
      period, an in-house period during which AZD8108 or placebo will be administered orally as a
      solution, and a 4- to 10-day follow-up period after discharge.
In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be
      randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts
      (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108
      and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose
      of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose
      portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be
      randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be
      randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each
      subject will receive twelve doses of either AZD8108 or placebo
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal
time frame: Day -1 to 7 days after last dose
description: Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal
measure: Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108
time frame: Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose
description: Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108
measure: Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose
description: Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6
measure: Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose
description: Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12
measure: Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose
description: Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12
measure: Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose
description: Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108
measure: Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108
time frame: Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose
description: Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6
measure: Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose
description: Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12
measure: Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose
description: Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108
measure: Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108
time frame: Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose
description: Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)
measure: Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108
time frame: Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose
description: Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12
measure: Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108
time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose
description: Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12
measure: Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD
time frame: Day 12 compared to Day 1
description: Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]
measure: EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
time frame: 8 hours after dose
description: EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest
measure: EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
time frame: 8 hours after dose
description: EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest
measure: EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
time frame: 8 hours after dose
description: EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest
arm group label: AZD8108
arm group type: Experimental
description: Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108
arm group label: Placebo to match AZD8108
arm group type: Placebo Comparator
description: Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo
intervention type: Drug
intervention name: AZD8108
description: Drug: AZD8108 Single or Multiple doses administered orally as a solution.
arm group label: AZD8108
intervention type: Drug
intervention name: Placebo
description: Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution
arm group label: Placebo to match AZD8108
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mina Pastagia, MD, MS
role: Principal Investigator
affiliation: Clinilabs, Inc.
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Conversion of AZD8108 to active moiety AZD6567 was rapid, concentrations of AZD8108 were almost all below the level of quantification, no PK parameters were calculable for AZD8108 concentrations.
point of contact: 