<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/NCT03036163</url>
  </required_header>
  <id_info>
    <org_study_id>PBTZ169-Z00-C01-1</org_study_id>
    <nct_id>NCT03036163</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of PBTZ169</brief_title>
  <official_title>Open-label Prospective Noncomparative Study of Safety, Tolerability and Pharmacokinetics of PBTZ169 After Single and Multiple Fasting Oral Administration in Increasing Doses in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nearmedic Plus LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>OCT LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nearmedic Plus LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending&#xD;
      dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after&#xD;
      single and multiple oral administration&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending&#xD;
      dose randomized cohort study of PBTZ169 (capsules 40 mg) in adult man healthy volunteers&#xD;
      after single and multiple oral fasting administration. Study was conducted in one study&#xD;
      center in Russian Federation. The study included two stages:&#xD;
&#xD;
        -  Stage 1 - single oral fasting administration with dose escalation in 5 cohorts 6 healthy&#xD;
           man volunteers each in main groups (plus 1 back-up volunteer in every group);&#xD;
&#xD;
        -  Stage 2 - multiple oral fasting administration with dose escalation in 2 cohorts 6&#xD;
           healthy man volunteers each in main groups (plus 1 back-up volunteer in every group).&#xD;
&#xD;
      Screening procedures for each cohort performed within 7 days before the drug prescription and&#xD;
      after the end of administration period in previous cohort. Screening in cohorts 2 and 6 was&#xD;
      started only after safety tolerability and PK data analysis of previous cohorts.&#xD;
&#xD;
      All volunteers met the study inclusion/exclusion criteria was included successively into the&#xD;
      following cohorts on Stage 1 (actual data):&#xD;
&#xD;
        -  Cohort 1 (C1) - 6 volunteers of the main group each of whom received once single dose of&#xD;
           the drug - 1 capsule containing 40 mg of PBTZ169;&#xD;
&#xD;
        -  Cohort 2 (C2) - 6 volunteers of the main group each of whom received once 80 mg of&#xD;
           PBTZ169 (2 capsules 40 mg);&#xD;
&#xD;
        -  Cohort 3 (C3) - 6 volunteers of the main group each of whom received once 160 mg of&#xD;
           PBTZ169 (4 capsules 40 mg);&#xD;
&#xD;
        -  Cohort 4 (C4) - 6 volunteers of the main group each of whom received once 320 mg of&#xD;
           PBTZ169 (8 capsules 40 mg);&#xD;
&#xD;
        -  Cohort 5 (C5) - 6 volunteers of the main group each of whom received once 640 mg of&#xD;
           PBTZ169 (16 capsules 40 mg).&#xD;
&#xD;
      On Stage 2 (actual data):&#xD;
&#xD;
        -  Cohort 6 (C6) - 5 volunteers of the main group each of whom received 320 mg of PBTZ169&#xD;
           (8 capsules 40 mg) once daily for 14 days;&#xD;
&#xD;
        -  Cohort 7 (C7) - 5 volunteers of the main group each of whom received 640 mg of PBTZ169&#xD;
           (16 capsules 40 mg) once daily for 14 days.&#xD;
&#xD;
      Safety was assessed throughout the study. For every volunteer series of urine and venous&#xD;
      blood samples was collected for the safety, tolerability and PK assessment of PBTZ169.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Drug-related Adverse Events [Safety and Tolerability]</measure>
    <time_frame>14±1 days after the drug administration (up to last visit time point)</time_frame>
    <description>The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration (Сmax) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>Up to 72 hours after the last drug administration:&#xD;
Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Concentration (Tmax) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve (AUC0-∞)</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>In the time interval from 0 to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Half-life Time (T1/2) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plasma Retention Time (MRT) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total (Plasma) Clearance (Cl) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (Vd) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Constant (Kel) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) &amp; 640 mg (Cohorts 5 and 7, total 11 volunters) were combined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (Clren) of PBTZ169</measure>
    <time_frame>Up to 24 hours after the drug administration</time_frame>
    <description>The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Steady State Plasma Concentration (Cmax,ss) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>For cohorts 6 and 7 (multiple administration) only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Steady State Concentration (Tmax,ss) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>For cohorts 6 and 7 (multiple administration) only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve in Steady State (AUCss) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>For cohorts 6 and 7 (multiple administration) only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Steady State Distribution (Vd,ss) of PBTZ169</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>For cohorts 6 and 7 (multiple administration) only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve (AUC0-t)</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>The area under the concentration-time curve from 0 to last blood sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t/AUC0-∞</measure>
    <time_frame>Up to 72 hours after the last drug administration</time_frame>
    <description>AUC0-t/AUC0-∞ ratio</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 male healthy volunteers each of whom received once daily for 14 days 320 mg of PBTZ169 (8 capsules 40 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 male healthy volunteers each of whom received once daily for 14 days 640 mg of PBTZ169 (16 capsules 40 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 40 mg</intervention_name>
    <description>40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 80 mg</intervention_name>
    <description>80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
    <arm_group_label>Cohort 2</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 160 mg</intervention_name>
    <description>160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
    <arm_group_label>Cohort 3</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 320 mg</intervention_name>
    <description>320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
    <arm_group_label>Cohort 4</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 640 mg</intervention_name>
    <description>640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
    <arm_group_label>Cohort 5</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 320 mg (multiple administration)</intervention_name>
    <description>320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
    <arm_group_label>Cohort 6</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBTZ169 - 640 mg (multiple administration)</intervention_name>
    <description>640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
    <arm_group_label>Cohort 7</arm_group_label>
    <other_name>PBTZ169</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent received from a volunteer.&#xD;
&#xD;
          2. Man aged 18 to 45 years old, inclusive.&#xD;
&#xD;
          3. Body mass index of 18.5-25 kg/m2.&#xD;
&#xD;
          4. Verified diagnosis: &quot;healthy&quot; according to data of standard clinical, laboratory and&#xD;
             instrumental examination methods performed at screening:&#xD;
&#xD;
               -  Absence of deviations of physical examination parameters and vital signs&#xD;
                  (systolic blood pressure - 100-129 mm Hg, inclusive; diastolic blood pressure -&#xD;
                  70-89 mm Hg, inclusive; heart rate - 60-80 bpm, inclusive);&#xD;
&#xD;
               -  Absence of deviations of laboratory parameters (complete blood count, blood&#xD;
                  biochemistry, urinalysis and tests for HIV, HBV, HCV, syphilis);&#xD;
&#xD;
               -  Normal parameters of 12-lead ECG;&#xD;
&#xD;
               -  Normal results of photofluorographic or X-ray examination (the results received&#xD;
                  maximum 6 months before screening can be used).&#xD;
&#xD;
          5. Ability, according to investigators opinion, to comply with all requirements of the&#xD;
             protocol.&#xD;
&#xD;
          6. Agreement to use double contraception method during the study participation and for 3&#xD;
             months after the test drug administration - combination of male condom with not less&#xD;
             than one of the following methods:&#xD;
&#xD;
               -  female partner using hormonal contraception;&#xD;
&#xD;
               -  using aerosols, creams, suppositories and other agents containing spermicides;&#xD;
&#xD;
               -  female partner using intrauterine device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Aggravated allergic history, including presence of at least one episode of drug&#xD;
             allergy.&#xD;
&#xD;
          2. Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine systems, ENT and&#xD;
             gastrointestinal, hepatic, renal, blood and cutaneous diseases.&#xD;
&#xD;
          3. Chronic diseases of eyes except for mild to moderate myopia, hypermetropia and&#xD;
             astigmatism.&#xD;
&#xD;
          4. Gastrointestinal surgeries (except for appendectomy performed not less than 1 year&#xD;
             before screening).&#xD;
&#xD;
          5. Acute infections within less than 4 weeks before screening.&#xD;
&#xD;
          6. Regular drug administration within less than 4 weeks before screening.&#xD;
&#xD;
          7. Regular administration or application (including topical) of hormonal drugs for more&#xD;
             than 1 week within less than 45 days before the screening.&#xD;
&#xD;
          8. Administration of drugs exerting evident effects on hemodynamics, hepatic function,&#xD;
             etc. (barbiturates, omeprazole, cimetidine, etc.) within less than 45 days before the&#xD;
             screening.&#xD;
&#xD;
          9. Positive tests for narcotic and psychotropic agents.&#xD;
&#xD;
         10. Donation (450 mL of blood or plasma) within less than 3 months before the screening.&#xD;
&#xD;
         11. Intake of more than 10 U of alcohol per week (1 unit of alcohol is equivalent to 500&#xD;
             mL of beer, 200 mL of vine or 50 mL of strong alcoholic drink) or historical data on&#xD;
             alcoholism, narcomania, drug abuse.&#xD;
&#xD;
         12. Mental illnesses.&#xD;
&#xD;
         13. Smoking within half a year before the screening.&#xD;
&#xD;
         14. Previous participation in this clinical study and withdrawal from it due to any&#xD;
             reason.&#xD;
&#xD;
         15. Participation in other clinical studies of drugs within less than 6 months before the&#xD;
             screening.&#xD;
&#xD;
         16. Planned conception or sperm donation during the study after the test drug&#xD;
             administration or during 3 months after the date of drug administration.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>March 26, 2020</results_first_submitted>
  <results_first_submitted_qc>March 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2020</results_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macozinone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03036163/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="P5">
          <title>Cohort 5</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="P6">
          <title>Cohort 6</title>
          <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
        </group>
        <group group_id="P7">
          <title>Cohort 7</title>
          <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="5"/>
              </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="5"/>
                <participants group_id="P7" count="5"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="B4">
          <title>Cohort 4</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="B5">
          <title>Cohort 5</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="B6">
          <title>Cohort 6</title>
          <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
        </group>
        <group group_id="B7">
          <title>Cohort 7</title>
          <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
        </group>
        <group group_id="B8">
          <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="5"/>
            <count group_id="B7" value="5"/>
            <count group_id="B8" value="40"/>
          </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="28.8" spread="5.00"/>
                    <measurement group_id="B2" value="27.8" spread="5.64"/>
                    <measurement group_id="B3" value="31.8" spread="6.55"/>
                    <measurement group_id="B4" value="31.2" spread="6.85"/>
                    <measurement group_id="B5" value="29.0" spread="7.18"/>
                    <measurement group_id="B6" value="22.6" spread="2.61"/>
                    <measurement group_id="B7" value="28.6" spread="6.50"/>
                    <measurement group_id="B8" value="27.6" spread="5.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="40"/>
                  </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_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="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</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_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Drug-related Adverse Events [Safety and Tolerability]</title>
        <description>The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted</description>
        <time_frame>14±1 days after the drug administration (up to last visit time point)</time_frame>
        <population>Safety population: subjects who received at least one dose of PBTZ169. The population was used for the analysis and evaluation of the demographic and other baseline data and all safety parameters including AEs, physical examination, evaluation of the vital signs, previous and current therapy, ECG, all laboratory tests</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Drug-related Adverse Events [Safety and Tolerability]</title>
          <description>The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted</description>
          <population>Safety population: subjects who received at least one dose of PBTZ169. The population was used for the analysis and evaluation of the demographic and other baseline data and all safety parameters including AEs, physical examination, evaluation of the vital signs, previous and current therapy, ECG, all laboratory tests</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Plasma Concentration (Сmax) of PBTZ169</title>
        <description>Up to 72 hours after the last drug administration:&#xD;
Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>Pharmacokinetics analysis population (PKA): C1-5: sbjs who received PBTZ169 and had at least one measurement of PBTZ169 concentration; C6-7: sbjs who received PBTZ169 at least 7 times and had measurements of PBTZ169 concentration after the first and seventh administration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Plasma Concentration (Сmax) of PBTZ169</title>
          <description>Up to 72 hours after the last drug administration:&#xD;
Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)</description>
          <population>Pharmacokinetics analysis population (PKA): C1-5: sbjs who received PBTZ169 and had at least one measurement of PBTZ169 concentration; C6-7: sbjs who received PBTZ169 at least 7 times and had measurements of PBTZ169 concentration after the first and seventh administration.</population>
          <units>ng/ml</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.67" spread="15.28"/>
                    <measurement group_id="O2" value="66.99" spread="33.81"/>
                    <measurement group_id="O3" value="135.85" spread="46.32"/>
                    <measurement group_id="O4" value="156.25" spread="65.54"/>
                    <measurement group_id="O5" value="349.67" spread="145.92"/>
                    <measurement group_id="O6" value="190.82" spread="37.51"/>
                    <measurement group_id="O7" value="250.54" spread="144.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="243.22" spread="59.51"/>
                    <measurement group_id="O7" value="278.64" spread="70.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="300.55" spread="82.24"/>
                    <measurement group_id="O7" value="453.73" spread="111.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Concentration (Tmax) of PBTZ169</title>
        <description>Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Concentration (Tmax) of PBTZ169</title>
          <description>Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)</description>
          <population>PKA</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="1.50" upper_limit="4.00"/>
                    <measurement group_id="O2" value="1.50" lower_limit="0.75" upper_limit="3.50"/>
                    <measurement group_id="O3" value="2.00" lower_limit="0.75" upper_limit="2.50"/>
                    <measurement group_id="O4" value="2.50" lower_limit="0.75" upper_limit="5.00"/>
                    <measurement group_id="O5" value="1.50" lower_limit="0.75" upper_limit="3.00"/>
                    <measurement group_id="O6" value="1.50" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O7" value="1.50" lower_limit="0.75" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="2.00" lower_limit="1.50" upper_limit="4.00"/>
                    <measurement group_id="O7" value="2.00" lower_limit="0.75" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O7" value="2.00" lower_limit="1.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve (AUC0-∞)</title>
        <description>In the time interval from 0 to infinity</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA: C1-5 - SAD, C6-7 - MAD for 14 days</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve (AUC0-∞)</title>
          <description>In the time interval from 0 to infinity</description>
          <population>PKA: C1-5 - SAD, C6-7 - MAD for 14 days</population>
          <units>ng*h/ml</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="349.25" spread="206.53"/>
                    <measurement group_id="O2" value="452.83" spread="148.58"/>
                    <measurement group_id="O3" value="1096.36" spread="543.62"/>
                    <measurement group_id="O4" value="1329.65" spread="250.95"/>
                    <measurement group_id="O5" value="3028.04" spread="1286.88"/>
                    <measurement group_id="O6" value="1450.21" spread="586.73"/>
                    <measurement group_id="O7" value="1696.28" spread="993.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="2747.33" spread="795.07"/>
                    <measurement group_id="O7" value="3024.29" spread="726.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="3410.12" spread="1204.07"/>
                    <measurement group_id="O7" value="4358.90" spread="649.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Half-life Time (T1/2) of PBTZ169</title>
        <description>Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Half-life Time (T1/2) of PBTZ169</title>
          <description>Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)</description>
          <population>PKA</population>
          <units>h</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.306" spread="4.516"/>
                    <measurement group_id="O2" value="10.182" spread="3.663"/>
                    <measurement group_id="O3" value="16.147" spread="3.461"/>
                    <measurement group_id="O4" value="16.447" spread="2.947"/>
                    <measurement group_id="O5" value="18.175" spread="3.824"/>
                    <measurement group_id="O6" value="12.40" spread="5.72"/>
                    <measurement group_id="O7" value="9.98" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="12.62" spread="5.02"/>
                    <measurement group_id="O7" value="14.16" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="17.16" spread="4.35"/>
                    <measurement group_id="O7" value="17.95" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Plasma Retention Time (MRT) of PBTZ169</title>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Plasma Retention Time (MRT) of PBTZ169</title>
          <population>PKA</population>
          <units>h</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.70" spread="6.12"/>
                    <measurement group_id="O2" value="13.02" spread="4.26"/>
                    <measurement group_id="O3" value="15.44" spread="3.88"/>
                    <measurement group_id="O4" value="17.38" spread="3.68"/>
                    <measurement group_id="O5" value="19.30" spread="4.16"/>
                    <measurement group_id="O6" value="7.65" spread="0.61"/>
                    <measurement group_id="O7" value="7.70" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="8.35" spread="0.75"/>
                    <measurement group_id="O7" value="8.45" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="16.78" spread="1.71"/>
                    <measurement group_id="O7" value="17.89" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total (Plasma) Clearance (Cl) of PBTZ169</title>
        <description>The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Total (Plasma) Clearance (Cl) of PBTZ169</title>
          <description>The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ</description>
          <population>PKA</population>
          <units>L/h</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.35" spread="71.97"/>
                    <measurement group_id="O2" value="190.75" spread="52.79"/>
                    <measurement group_id="O3" value="173.96" spread="69.47"/>
                    <measurement group_id="O4" value="248.08" spread="47.99"/>
                    <measurement group_id="O5" value="240.40" spread="89.12"/>
                    <measurement group_id="O6" value="244.15" spread="74.982"/>
                    <measurement group_id="O7" value="462.83" spread="197.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="197.223" spread="45.706"/>
                    <measurement group_id="O7" value="310.74" spread="76.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="146.44" spread="45.573"/>
                    <measurement group_id="O7" value="224.79" spread="42.994"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution (Vd) of PBTZ169</title>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (Vd) of PBTZ169</title>
          <population>PKA</population>
          <units>L</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2762.47" spread="1052.08"/>
                    <measurement group_id="O2" value="2949.95" spread="1652.24"/>
                    <measurement group_id="O3" value="3903.25" spread="1354.34"/>
                    <measurement group_id="O4" value="5801.14" spread="1006.47"/>
                    <measurement group_id="O5" value="6359.85" spread="2861.493"/>
                    <measurement group_id="O6" value="3924.74" spread="401.074"/>
                    <measurement group_id="O7" value="6521.98" spread="2719.519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="2957.51" spread="1671.483"/>
                    <measurement group_id="O7" value="6114.55" spread="1680.928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="3392.46" spread="2005.822"/>
                    <measurement group_id="O7" value="4067.27" spread="2374.585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Elimination Constant (Kel) of PBTZ169</title>
        <description>Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) &amp; 640 mg (Cohorts 5 and 7, total 11 volunters) were combined</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Elimination Constant (Kel) of PBTZ169</title>
          <description>Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) &amp; 640 mg (Cohorts 5 and 7, total 11 volunters) were combined</description>
          <population>PKA</population>
          <units>1/h</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.052" spread="0.01329"/>
                    <measurement group_id="O2" value="0.077" spread="0.0266"/>
                    <measurement group_id="O3" value="0.063" spread="0.0082"/>
                    <measurement group_id="O4" value="0.066" spread="0.0212"/>
                    <measurement group_id="O5" value="0.066" spread="0.0151"/>
                    <measurement group_id="O6" value="0.066" spread="0.0212"/>
                    <measurement group_id="O7" value="0.066" spread="0.0151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Clearance (Clren) of PBTZ169</title>
        <description>The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)</description>
        <time_frame>Up to 24 hours after the drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O6">
            <title>Cohort 6</title>
            <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
          <group group_id="O7">
            <title>Cohort 7</title>
            <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (Clren) of PBTZ169</title>
          <description>The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)</description>
          <population>PKA</population>
          <units>mL/h</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="5"/>
                <count group_id="O7" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dosing day / Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.12" spread="7.62"/>
                    <measurement group_id="O2" value="12.64" spread="7.72"/>
                    <measurement group_id="O3" value="7.16" spread="3.80"/>
                    <measurement group_id="O4" value="11.81" spread="1.22"/>
                    <measurement group_id="O5" value="17.72" spread="6.37"/>
                    <measurement group_id="O6" value="8.5" spread="5.8"/>
                    <measurement group_id="O7" value="11.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</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="0"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="5.7" spread="3.3"/>
                    <measurement group_id="O7" value="7.6" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Steady State Plasma Concentration (Cmax,ss) of PBTZ169</title>
        <description>For cohorts 6 and 7 (multiple administration) only</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Steady State Concentration (Tmax,ss) of PBTZ169</title>
        <description>For cohorts 6 and 7 (multiple administration) only</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve in Steady State (AUCss) of PBTZ169</title>
        <description>For cohorts 6 and 7 (multiple administration) only</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Steady State Distribution (Vd,ss) of PBTZ169</title>
        <description>For cohorts 6 and 7 (multiple administration) only</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve (AUC0-t)</title>
        <description>The area under the concentration-time curve from 0 to last blood sampling</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve (AUC0-t)</title>
          <description>The area under the concentration-time curve from 0 to last blood sampling</description>
          <population>PKA</population>
          <units>ng*h/ml</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="260.47" spread="119.06"/>
                    <measurement group_id="O2" value="381.17" spread="149.39"/>
                    <measurement group_id="O3" value="994.49" spread="462.00"/>
                    <measurement group_id="O4" value="1193.70" spread="212.53"/>
                    <measurement group_id="O5" value="2880.86" spread="1219.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-t/AUC0-∞</title>
        <description>AUC0-t/AUC0-∞ ratio</description>
        <time_frame>Up to 72 hours after the last drug administration</time_frame>
        <population>PKA</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
          </group>
          <group group_id="O5">
            <title>Cohort 5</title>
            <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-t/AUC0-∞</title>
          <description>AUC0-t/AUC0-∞ ratio</description>
          <population>PKA</population>
          <units>ratio</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.784"/>
                    <measurement group_id="O2" value="0.829"/>
                    <measurement group_id="O3" value="0.917"/>
                    <measurement group_id="O4" value="0.899"/>
                    <measurement group_id="O5" value="0.951"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SAD: 14±1 days after PBTZ169 administration (Day 14±1); MAD: 21±1 days after the last (14th) PBTZ169 administration (Day 35±1).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 40 mg (1 capsule)&#xD;
PBTZ169 - 40 mg: 40 mg of PBTZ169 (1 capsule) orally once in fasting state</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 80 mg (2 capsules)&#xD;
PBTZ169 - 80 mg: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 160 mg (4 capsules)&#xD;
PBTZ169 - 160 mg: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="E4">
          <title>Cohort 4</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 320 mg (8 capsules)&#xD;
PBTZ169 - 320 mg: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="E5">
          <title>Cohort 5</title>
          <description>6 healthy volunteers each of whom received one single oral dose of PBTZ169 - 640 mg (16 capsules)&#xD;
PBTZ169 - 640 mg: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state</description>
        </group>
        <group group_id="E6">
          <title>Cohort 6</title>
          <description>5 healthy volunteers each of whom received а daily dose of 320 mg of PBTZ169 (8 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 320 mg (multiple administration): 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days</description>
        </group>
        <group group_id="E7">
          <title>Cohort 7</title>
          <description>5 healthy volunteers each of whom received a daily dose of 640 mg of PBTZ169 (16 capsules 40 mg) for 14 days&#xD;
PBTZ169 - 640 mg (multiple administration): 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</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="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <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="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" 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="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</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="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</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="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="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="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </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>There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Viсtoria Shcherbakova</name_or_title>
      <organization>Nearmedic Plus</organization>
      <phone>+7 (495) 741 49 89 ext 3869</phone>
      <email>Viktoriya.Shcherbakova@nearmedic.ru</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/NCT03036163
org study id: PBTZ169-Z00-C01-1
nct id: NCT03036163
lead sponsor: 
collaborator: 
has dmc: Yes
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending
      dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after
      single and multiple oral administration
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending
      dose randomized cohort study of PBTZ169 (capsules 40 mg) in adult man healthy volunteers
      after single and multiple oral fasting administration. Study was conducted in one study
      center in Russian Federation. The study included two stages:

        -  Stage 1 - single oral fasting administration with dose escalation in 5 cohorts 6 healthy
           man volunteers each in main groups (plus 1 back-up volunteer in every group);

        -  Stage 2 - multiple oral fasting administration with dose escalation in 2 cohorts 6
           healthy man volunteers each in main groups (plus 1 back-up volunteer in every group).

      Screening procedures for each cohort performed within 7 days before the drug prescription and
      after the end of administration period in previous cohort. Screening in cohorts 2 and 6 was
      started only after safety tolerability and PK data analysis of previous cohorts.

      All volunteers met the study inclusion/exclusion criteria was included successively into the
      following cohorts on Stage 1 (actual data):

        -  Cohort 1 (C1) - 6 volunteers of the main group each of whom received once single dose of
           the drug - 1 capsule containing 40 mg of PBTZ169;

        -  Cohort 2 (C2) - 6 volunteers of the main group each of whom received once 80 mg of
           PBTZ169 (2 capsules 40 mg);

        -  Cohort 3 (C3) - 6 volunteers of the main group each of whom received once 160 mg of
           PBTZ169 (4 capsules 40 mg);

        -  Cohort 4 (C4) - 6 volunteers of the main group each of whom received once 320 mg of
           PBTZ169 (8 capsules 40 mg);

        -  Cohort 5 (C5) - 6 volunteers of the main group each of whom received once 640 mg of
           PBTZ169 (16 capsules 40 mg).

      On Stage 2 (actual data):

        -  Cohort 6 (C6) - 5 volunteers of the main group each of whom received 320 mg of PBTZ169
           (8 capsules 40 mg) once daily for 14 days;

        -  Cohort 7 (C7) - 5 volunteers of the main group each of whom received 640 mg of PBTZ169
           (16 capsules 40 mg) once daily for 14 days.

      Safety was assessed throughout the study. For every volunteer series of urine and venous
      blood samples was collected for the safety, tolerability and PK assessment of PBTZ169.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Incidence of Drug-related Adverse Events [Safety and Tolerability]
time frame: 14±1 days after the drug administration (up to last visit time point)
description: The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted
measure: Peak Plasma Concentration (Сmax) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: Up to 72 hours after the last drug administration:
Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)
measure: Time to Reach Maximum Concentration (Tmax) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)
measure: Area Under the Concentration-time Curve (AUC0-∞)
time frame: Up to 72 hours after the last drug administration
description: In the time interval from 0 to infinity
measure: Plasma Half-life Time (T1/2) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)
measure: Mean Plasma Retention Time (MRT) of PBTZ169
time frame: Up to 72 hours after the last drug administration
measure: Total (Plasma) Clearance (Cl) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ
measure: Volume of Distribution (Vd) of PBTZ169
time frame: Up to 72 hours after the last drug administration
measure: Elimination Constant (Kel) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) & 640 mg (Cohorts 5 and 7, total 11 volunters) were combined
measure: Renal Clearance (Clren) of PBTZ169
time frame: Up to 24 hours after the drug administration
description: The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)
measure: Peak Steady State Plasma Concentration (Cmax,ss) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: For cohorts 6 and 7 (multiple administration) only
measure: Time to Reach Maximum Steady State Concentration (Tmax,ss) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: For cohorts 6 and 7 (multiple administration) only
measure: Area Under the Plasma Concentration Versus Time Curve in Steady State (AUCss) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: For cohorts 6 and 7 (multiple administration) only
measure: Volume of Steady State Distribution (Vd,ss) of PBTZ169
time frame: Up to 72 hours after the last drug administration
description: For cohorts 6 and 7 (multiple administration) only
measure: Area Under the Concentration-time Curve (AUC0-t)
time frame: Up to 72 hours after the last drug administration
description: The area under the concentration-time curve from 0 to last blood sampling
measure: AUC0-t/AUC0-∞
time frame: Up to 72 hours after the last drug administration
description: AUC0-t/AUC0-∞ ratio
arm group label: Cohort 1
arm group type: Experimental
description: 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 40 mg (1 capsule)
arm group label: Cohort 2
arm group type: Experimental
description: 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 80 mg (2 capsules)
arm group label: Cohort 3
arm group type: Experimental
description: 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 160 mg (4 capsules)
arm group label: Cohort 4
arm group type: Experimental
description: 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 320 mg (8 capsules)
arm group label: Cohort 5
arm group type: Experimental
description: 6 male healthy volunteers each of whom received once single oral dose of PBTZ169 - 640 mg (16 capsules)
arm group label: Cohort 6
arm group type: Experimental
description: 5 male healthy volunteers each of whom received once daily for 14 days 320 mg of PBTZ169 (8 capsules 40 mg)
arm group label: Cohort 7
arm group type: Experimental
description: 5 male healthy volunteers each of whom received once daily for 14 days 640 mg of PBTZ169 (16 capsules 40 mg)
intervention type: Drug
intervention name: PBTZ169 - 40 mg
description: 40 mg of PBTZ169 (1 capsule) orally once in fasting state
arm group label: Cohort 1
other name: PBTZ169
intervention type: Drug
intervention name: PBTZ169 - 80 mg
description: 80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
arm group label: Cohort 2
other name: PBTZ169
intervention type: Drug
intervention name: PBTZ169 - 160 mg
description: 160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
arm group label: Cohort 3
other name: PBTZ169
intervention type: Drug
intervention name: PBTZ169 - 320 mg
description: 320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
arm group label: Cohort 4
other name: PBTZ169
intervention type: Drug
intervention name: PBTZ169 - 640 mg
description: 640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
arm group label: Cohort 5
other name: PBTZ169
intervention type: Drug
intervention name: PBTZ169 - 320 mg (multiple administration)
description: 320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
arm group label: Cohort 6
other name: PBTZ169
intervention type: Drug
intervention name: PBTZ169 - 640 mg (multiple administration)
description: 640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
arm group label: Cohort 7
other name: PBTZ169
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Macozinone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 