<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/NCT03784300</url>
  </required_header>
  <id_info>
    <org_study_id>PTI-125-01</org_study_id>
    <secondary_id>1R44AG056166</secondary_id>
    <nct_id>NCT03784300</nct_id>
  </id_info>
  <brief_title>A Safety Study of PTI-125 in Healthy Volunteers</brief_title>
  <official_title>A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pain Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Cassava Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending&#xD;
      Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase I, single center, randomized, double-blind, placebo-controlled, single&#xD;
      ascending dose (SAD) study in healthy volunteers, 18 to 45 years of age. A total of&#xD;
      twenty-four (24) subjects were enrolled into the study in one of three dose cohorts. Each&#xD;
      cohort contained eight subjects; six subjects received PTI-125 and two received placebo.&#xD;
      Three doses of PTI-125 oral solution (50, 100, and 200 mg) or placebo solution were&#xD;
      administered to respective cohorts.&#xD;
&#xD;
      The study included a screening period (Day -28 to Day -1), an inpatient treatment period (Day&#xD;
      0 through Day 4), and a follow-up visit (Day 7). Subjects reported to the clinic on the day&#xD;
      before dosing and were randomized to receive either a single dose of orally administered&#xD;
      PTI-125 or placebo. Each dose was administered following an overnight fast of at least 10&#xD;
      hours.&#xD;
&#xD;
      For each dose level, dosing was staggered such that two subjects (one active and one placebo)&#xD;
      were dosed prior to the rest of the group. After a minimum of 24 hours and review of all&#xD;
      24-hour safety assessments (electrocardiogram [ECG], a brief physical examination, vital&#xD;
      signs, and laboratory assessments) an independent Data Safety Monitoring Board/Data&#xD;
      Monitoring Committee (DSMB/DMC) determined whether the remaining 6 subjects were to be dosed.&#xD;
&#xD;
      Pharmacokinetic blood samples were obtained prior to dosing and at specified intervals during&#xD;
      the study (0-72 hours post-dose). Blood draws for laboratory testing were performed prior to&#xD;
      dosing and at 24 hours post dose. After safety assessments of ECG, vital signs, and a brief&#xD;
      physical exam at 72 hours, subjects were discharged from the clinic and returned 7 days&#xD;
      post-dose for a final safety assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">March 27, 2018</completion_date>
  <primary_completion_date type="Actual">October 9, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The peak drug concentration will be obtained directly from the data without interpolation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Plasma Concentration (Tmax) (Tmax)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The time to peak drug concentration will be obtained directly from the data without interpolation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Last Quantifiable Plasma Concentration (Tlast)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Last Quantifiable Plasma Concentration (Clast)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination Rate Constant (λz)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The elimination rate constant (λz) will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Termination Elimination Half-Life (T1/2)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The terminal elimination half-life (T1/2) will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve to Infinity (AUCinf)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The percentage of AUCinf based on extrapolation (AUCextrap[%]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Clearance (Cl/F)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>The apparent oral clearance will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution (Vz/F)</measure>
    <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
    <description>Vz/F, apparent volume of distribution will be calculated.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Alzheimer Disease, Early Onset</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>50 mg PTI-125</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 mg PTI-125 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg PTI-125</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg PTI-125 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg PTI-125</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg PTI-125 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50 mg PTI-125</intervention_name>
    <description>PTI-125 50 mg Oral Solution</description>
    <arm_group_label>50 mg PTI-125</arm_group_label>
    <arm_group_label>50 mg PTI-125 Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100 mg PTI-125</intervention_name>
    <description>PTI-125 100 mg Oral Solution</description>
    <arm_group_label>100 mg PTI-125</arm_group_label>
    <arm_group_label>100 mg PTI-125 Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>200 mg PTI-125</intervention_name>
    <description>PTI-125 200 mg Oral Solution</description>
    <arm_group_label>200 mg PTI-125</arm_group_label>
    <arm_group_label>200 mg PTI-125 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects between 18 and 45 years of age, inclusive.&#xD;
&#xD;
          -  The subject has a body mass index (BMI) within 18-30 kg/m2 (inclusive).&#xD;
&#xD;
          -  The subject is in good health as determined by medical history and physical&#xD;
             examination and clinical laboratory parameters.&#xD;
&#xD;
          -  The subject is willing and able to speak, read, and understand English and provide&#xD;
             written informed consent.&#xD;
&#xD;
          -  The subject is a non-smoker for at least 12 months. If a former smoker, the reason for&#xD;
             stopping must be evaluated.&#xD;
&#xD;
          -  Females who are physically incapable of childbearing defined as postmenopausal, or&#xD;
             surgically sterile (hysterectomy, bilateral tubal ligation, bilateral oophorectomy or&#xD;
             an Essure procedure). Appropriate documentation (ex; medical record) of the surgical&#xD;
             sterilization procedure to be obtained and held within the subject's study file.&#xD;
&#xD;
          -  The subject must agree to comply with the drawing of blood samples for the PK&#xD;
             assessments.&#xD;
&#xD;
          -  The subject is willing and able to comply with all testing and requirements defined in&#xD;
             the protocol.&#xD;
&#xD;
          -  The subject is willing and able to remain at the study site unit for the duration of&#xD;
             the confinement period and return for the outpatient visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has any relevant deviations from normal in physical examination,&#xD;
             electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the&#xD;
             investigator.&#xD;
&#xD;
          -  The subject has had a clinically significant illness within 30 days of Check-in.&#xD;
&#xD;
          -  The subject has a history of significant neurological, hepatic, renal, endocrine,&#xD;
             cardiovascular, gastrointestinal, pulmonary, or metabolic disease.&#xD;
&#xD;
          -  The subject has used any prescription medication within 14 days of dosing or overthe-&#xD;
             counter (OTC) medication within 48 h of dosing or intends to use any prescription&#xD;
             medication or OTC medication during the study that may interfere with the evaluation&#xD;
             of study medication.&#xD;
&#xD;
          -  The subject has used alcohol, caffeine or xanthine-containing products 48 h before&#xD;
             dosing or intends to use any of these products during the study.&#xD;
&#xD;
          -  The subject has used grapefruit, grapefruit juice, or grapefruit-containing products&#xD;
             days before dosing or intends to use any of these products during the study.&#xD;
&#xD;
          -  The subject has a history of substance abuse or a positive ethanol breath test, urine&#xD;
             cotinine, or urine drug screen at screening or at check-in. The subject has a positive&#xD;
             serum hepatitis B surface antigen or positive HCV antibody test at the Screening&#xD;
             Visit.&#xD;
&#xD;
          -  The subject has a positive HIV test at the Screening Visit.&#xD;
&#xD;
          -  Female subject is pregnant or breastfeeding.&#xD;
&#xD;
          -  The subject has received an investigational drug within 30 days of Check-in.&#xD;
&#xD;
          -  The subject has donated or lost a significant volume of blood (&gt;450 mL) within 4 weeks&#xD;
             prior to the study.&#xD;
&#xD;
          -  The subject is unwilling to reside in the study unit for the duration of the study or&#xD;
             to cooperate fully with the investigator or site personnel.&#xD;
&#xD;
          -  The subject has an AST/ALT or total bilirubin greater than the ULN. One repeat test&#xD;
             will be allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George J Atiee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Worldwide Clinical Trials</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Worldwide Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <results_first_submitted>July 27, 2020</results_first_submitted>
  <results_first_submitted_qc>May 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2021</results_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03784300/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>50 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
        </group>
        <group group_id="P2">
          <title>50 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
        </group>
        <group group_id="P3">
          <title>100 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
        </group>
        <group group_id="P4">
          <title>100 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
        </group>
        <group group_id="P5">
          <title>200 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
        </group>
        <group group_id="P6">
          <title>200 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</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="2"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>50 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
        </group>
        <group group_id="B2">
          <title>50 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
        </group>
        <group group_id="B3">
          <title>100 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
        </group>
        <group group_id="B4">
          <title>100 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
        </group>
        <group group_id="B5">
          <title>200 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
        </group>
        <group group_id="B6">
          <title>200 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
        </group>
        <group group_id="B7">
          <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="2"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="2"/>
            <count group_id="B7" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.2" lower_limit="18" upper_limit="45"/>
                    <measurement group_id="B2" value="31.8" lower_limit="18" upper_limit="45"/>
                    <measurement group_id="B3" value="35.3" lower_limit="18" upper_limit="45"/>
                    <measurement group_id="B4" value="31.8" lower_limit="18" upper_limit="45"/>
                    <measurement group_id="B5" value="35.8" lower_limit="18" upper_limit="45"/>
                    <measurement group_id="B6" value="31.8" lower_limit="18" upper_limit="45"/>
                    <measurement group_id="B7" value="35.3" lower_limit="18" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="20"/>
                  </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_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_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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="11"/>
                  </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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Plasma Concentration (Cmax)</title>
        <description>The peak drug concentration will be obtained directly from the data without interpolation.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax)</title>
          <description>The peak drug concentration will be obtained directly from the data without interpolation.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="315" spread="96.6"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="550" spread="146"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="1240" spread="276"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Maximum Plasma Concentration (Tmax) (Tmax)</title>
        <description>The time to peak drug concentration will be obtained directly from the data without interpolation</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Plasma Concentration (Tmax) (Tmax)</title>
          <description>The time to peak drug concentration will be obtained directly from the data without interpolation</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>hours</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="0.69"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="1.08" spread="0.48"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="1.28" spread="0.57"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Last Quantifiable Plasma Concentration (Tlast)</title>
        <description>The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Last Quantifiable Plasma Concentration (Tlast)</title>
          <description>The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>hours</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="16.4"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="46.0" spread="4.6"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="50.00" spread="11.8"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Last Quantifiable Plasma Concentration (Clast)</title>
        <description>The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Last Quantifiable Plasma Concentration (Clast)</title>
          <description>The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="0.495"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="0.795" spread="0.294"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="0.806" spread="0.292"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Elimination Rate Constant (λz)</title>
        <description>The elimination rate constant (λz) will be calculated.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Elimination Rate Constant (λz)</title>
          <description>The elimination rate constant (λz) will be calculated.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>1/hour</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.141" spread="0.0539"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="0.157" spread="0.0155"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="0.144" spread="0.0516"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Termination Elimination Half-Life (T1/2)</title>
        <description>The terminal elimination half-life (T1/2) will be calculated.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Termination Elimination Half-Life (T1/2)</title>
          <description>The terminal elimination half-life (T1/2) will be calculated.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>hours</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.05" spread="3.87"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="4.45" spread="0.39"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="5.93" spread="3.87"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC)</title>
        <description>The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC)</title>
          <description>The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>h*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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2040" spread="893"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="3130" spread="1150"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="8130" spread="1530"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve to Infinity (AUCinf)</title>
        <description>The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve to Infinity (AUCinf)</title>
          <description>The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>h*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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2180" spread="897"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="3260" spread="1150"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="8250" spread="1530"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).</title>
        <description>The percentage of AUCinf based on extrapolation (AUCextrap[%]).</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).</title>
          <description>The percentage of AUCinf based on extrapolation (AUCextrap[%]).</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
          <units>percent extrapolated</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.410" spread="0.187"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O3" value="0.151" spread="0.0366"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                    <measurement group_id="O5" value="0.144" spread="0.0156"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk values N/A for placebo subjects</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oral Clearance (Cl/F)</title>
        <description>The apparent oral clearance will be calculated.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Clearance (Cl/F)</title>
          <description>The apparent oral clearance will be calculated.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="8.42"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk value not available as these are placebo patients</measurement>
                    <measurement group_id="O3" value="33.0" spread="8.16"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk value not available as these are placebo patients</measurement>
                    <measurement group_id="O5" value="24.9" spread="4.53"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk value not available as these are placebo patients</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Volume of Distribution (Vz/F)</title>
        <description>Vz/F, apparent volume of distribution will be calculated.</description>
        <time_frame>Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.</time_frame>
        <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O2">
            <title>50 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
          </group>
          <group group_id="O3">
            <title>100 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O4">
            <title>100 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
          </group>
          <group group_id="O5">
            <title>200 mg PTI-125</title>
            <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
          <group group_id="O6">
            <title>200 mg PTI-125 Placebo</title>
            <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (Vz/F)</title>
          <description>Vz/F, apparent volume of distribution will be calculated.</description>
          <population>Separate dose cohorts of 6 active and 2 placebo received 50, 100, or 200 mg. A sentinel dose group of 1 active and 1 placebo preceded each full dose cohort.</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="2"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199" spread="64.9"/>
                    <measurement group_id="O2" value="NA" spread="NA">Pk value not available as these are placebo patients</measurement>
                    <measurement group_id="O3" value="215" spread="64.8"/>
                    <measurement group_id="O4" value="NA" spread="NA">Pk value not available as these are placebo patients</measurement>
                    <measurement group_id="O5" value="214" spread="154"/>
                    <measurement group_id="O6" value="NA" spread="NA">Pk value not available as these are placebo patients</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>50 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
        </group>
        <group group_id="E2">
          <title>50 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.&#xD;
50 mg PTI-125: PTI-125 50 mg Oral Solution</description>
        </group>
        <group group_id="E3">
          <title>100 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
        </group>
        <group group_id="E4">
          <title>100 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.&#xD;
100 mg PTI-125: PTI-125 100 mg Oral Solution</description>
        </group>
        <group group_id="E5">
          <title>200 mg PTI-125</title>
          <description>Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</description>
        </group>
        <group group_id="E6">
          <title>200 mg PTI-125 Placebo</title>
          <description>Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.&#xD;
200 mg PTI-125: PTI-125 200 mg Oral Solution</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="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
              </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="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>medDRA</default_vocab>
        <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="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>transient musculoskeletal wall pain</sub_title>
                <description>One subject in the 200 mg group reported transient musculoskeletal wall pain</description>
                <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="2"/>
                <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="2"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>lightheadedness</sub_title>
                <description>lightheadedness upon standing was resported for a subject in the 100 mg group at 1 h post-dose</description>
                <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="2"/>
                <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="2"/>
                <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="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <description>The same subject in the 200 mg group who reported transient musculoskeletal wall pain, also reported acne</description>
                <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="2"/>
                <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="2"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael R Marsman, PharmD</name_or_title>
      <organization>Cassava Sciences</organization>
      <phone>5125822173</phone>
      <email>mmarsman@cassavasciences.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784300
org study id: PTI-125-01
secondary id: 1R44AG056166
nct id: NCT03784300
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending
      Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
This was a Phase I, single center, randomized, double-blind, placebo-controlled, single
      ascending dose (SAD) study in healthy volunteers, 18 to 45 years of age. A total of
      twenty-four (24) subjects were enrolled into the study in one of three dose cohorts. Each
      cohort contained eight subjects; six subjects received PTI-125 and two received placebo.
      Three doses of PTI-125 oral solution (50, 100, and 200 mg) or placebo solution were
      administered to respective cohorts.

      The study included a screening period (Day -28 to Day -1), an inpatient treatment period (Day
      0 through Day 4), and a follow-up visit (Day 7). Subjects reported to the clinic on the day
      before dosing and were randomized to receive either a single dose of orally administered
      PTI-125 or placebo. Each dose was administered following an overnight fast of at least 10
      hours.

      For each dose level, dosing was staggered such that two subjects (one active and one placebo)
      were dosed prior to the rest of the group. After a minimum of 24 hours and review of all
      24-hour safety assessments (electrocardiogram [ECG], a brief physical examination, vital
      signs, and laboratory assessments) an independent Data Safety Monitoring Board/Data
      Monitoring Committee (DSMB/DMC) determined whether the remaining 6 subjects were to be dosed.

      Pharmacokinetic blood samples were obtained prior to dosing and at specified intervals during
      the study (0-72 hours post-dose). Blood draws for laboratory testing were performed prior to
      dosing and at 24 hours post dose. After safety assessments of ECG, vital signs, and a brief
      physical exam at 72 hours, subjects were discharged from the clinic and returned 7 days
      post-dose for a final safety assessment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Maximum Plasma Concentration (Cmax)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The peak drug concentration will be obtained directly from the data without interpolation.
measure: Time to Maximum Plasma Concentration (Tmax) (Tmax)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The time to peak drug concentration will be obtained directly from the data without interpolation
measure: Time to Last Quantifiable Plasma Concentration (Tlast)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.
measure: Last Quantifiable Plasma Concentration (Clast)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration
measure: Elimination Rate Constant (λz)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The elimination rate constant (λz) will be calculated.
measure: Termination Elimination Half-Life (T1/2)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The terminal elimination half-life (T1/2) will be calculated.
measure: Area Under the Curve (AUC)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.
measure: Area Under the Curve to Infinity (AUCinf)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.
measure: Percent Extrapolated of Area Under the Curve to Infinity (AUCextrap[%]).
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The percentage of AUCinf based on extrapolation (AUCextrap[%]).
measure: Oral Clearance (Cl/F)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: The apparent oral clearance will be calculated.
measure: Volume of Distribution (Vz/F)
time frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours.
description: Vz/F, apparent volume of distribution will be calculated.
arm group label: 50 mg PTI-125
arm group type: Active Comparator
description: Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
arm group label: 50 mg PTI-125 Placebo
arm group type: Placebo Comparator
description: Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
arm group label: 100 mg PTI-125
arm group type: Active Comparator
description: Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
arm group label: 100 mg PTI-125 Placebo
arm group type: Placebo Comparator
description: Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
arm group label: 200 mg PTI-125
arm group type: Active Comparator
description: Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
arm group label: 200 mg PTI-125 Placebo
arm group type: Placebo Comparator
description: Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
intervention type: Drug
intervention name: 50 mg PTI-125
description: PTI-125 50 mg Oral Solution
arm group label: 50 mg PTI-125
arm group label: 50 mg PTI-125 Placebo
intervention type: Drug
intervention name: 100 mg PTI-125
description: PTI-125 100 mg Oral Solution
arm group label: 100 mg PTI-125
arm group label: 100 mg PTI-125 Placebo
intervention type: Drug
intervention name: 200 mg PTI-125
description: PTI-125 200 mg Oral Solution
arm group label: 200 mg PTI-125
arm group label: 200 mg PTI-125 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: George J Atiee, MD
role: Principal Investigator
affiliation: Worldwide Clinical Trials
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 