<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/NCT04442945</url>
  </required_header>
  <id_info>
    <org_study_id>ANAVEX3-71-001</org_study_id>
    <nct_id>NCT04442945</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of ANAVEX3-71</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled, Phase 1 Safety and Tolerability, and Pharmacokinetics Study of ANAVEX3-71</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anavex Life Sciences Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anavex Australia Pty Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Anavex Life Sciences Corp.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety,&#xD;
      tolerability, bioavailability, pharmacokinetics, and pharmacodynamics&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK,&#xD;
      PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of safety and tolerability of ANAVEX3-71 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) of ANAVEX3-71</measure>
    <time_frame>30 days</time_frame>
    <description>Serum concentration of ANAVEX3-71 at specified time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) for ANAVEX3-71</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate Cmax for serum concentration of ANAVEX3-71 at specified time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve concentration (AUC) for ANAVEX3-71</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate AUC for serum concentration of ANAVEX3-71 at specified time points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on ECG, including the ECG QT Interval</measure>
    <time_frame>30 days</time_frame>
    <description>To characterize the effect on ECG, including the ECG QT Interval for ANAVEX3-71</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ANAVEX3-71 Oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to four single ascending doses of ANAVEX3-71 administered orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm Oral</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ANAVEX3-71</intervention_name>
    <description>Active oral dose of ANAVEX3-71</description>
    <arm_group_label>ANAVEX3-71 Oral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral placebo</description>
    <arm_group_label>Placebo arm Oral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, male or female between 18 and 55 years of age, inclusive.&#xD;
&#xD;
          -  Body mass index (BMI) between 19-28 kg/m2 and within a body weight of ≥ 60 kg and ≤&#xD;
             120 kg.&#xD;
&#xD;
          -  Female subjects must be of non-childbearing potential (defined as postmenopausal for&#xD;
             at least 2 years or surgically sterile at least 6 months prior to dosing) or must be&#xD;
             using adequate contraception.&#xD;
&#xD;
          -  Subject is judged by the investigator to be in generally good health at screening&#xD;
             based upon the results of a medical history, physical examination, laboratory profile,&#xD;
             and 12-lead electrocardiogram (ECG).&#xD;
&#xD;
          -  Non-smoker (no tobacco use within past 3 months).&#xD;
&#xD;
          -  Subject is willing to comply with the study protocol, in the investigator's judgement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history or presence of cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal, endocrinological, dermatological, neurological, psychiatric,&#xD;
             hematological (including myelosuppression and bleeding disorders) or&#xD;
             immunological/autoimmune disorder(s), and/or any condition that could constitute a&#xD;
             potential safety risk factor or could alter the absorption, distribution, metabolism&#xD;
             or elimination of the study drugs.&#xD;
&#xD;
          -  Positive test result on Hepatitis B surface antigen (HBsAg) or is Hepatitis C virus&#xD;
             antibody (HCV-Ab) positive or positive HIV-1 and/or -2 serology.&#xD;
&#xD;
          -  Subject has a history of chronic alcohol abuse within the last 2 years, or has a&#xD;
             positive alcohol test or is known to have excessive alcohol intake.&#xD;
&#xD;
          -  History of substance abuse, known drug addiction, or positive test for drugs of abuse.&#xD;
&#xD;
          -  Subject has participated in another clinical trial of an investigational drug (or a&#xD;
             medical device) within the last 3 months or is currently participating in another&#xD;
             trial of an investigational drug (or a medical device).&#xD;
&#xD;
          -  Female subject who is pregnant or lactating or planning a pregnancy.&#xD;
&#xD;
          -  A history of major mental illness that in the opinion of the Investigator may affect&#xD;
             the ability of the subject to participate in the study (psychosis is to be&#xD;
             disqualified).&#xD;
&#xD;
          -  Subject has a condition the Investigator believes would interfere with the ability to&#xD;
             provide informed consent or comply with study instructions, or that might confound the&#xD;
             interpretation of the study results or put the subject at undue risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CMAX Clinical Research Pty Ltd</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 15, 2022</last_update_submitted>
  <last_update_submitted_qc>January 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04442945
org study id: ANAVEX3-71-001
nct id: NCT04442945
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety,
      tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK,
      PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evaluation of safety and tolerability of ANAVEX3-71 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
time frame: 30 days
description: Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
measure: Pharmacokinetics (PK) of ANAVEX3-71
time frame: 30 days
description: Serum concentration of ANAVEX3-71 at specified time points
measure: Maximum plasma concentration (Cmax) for ANAVEX3-71
time frame: 30 days
description: Evaluate Cmax for serum concentration of ANAVEX3-71 at specified time points
measure: Area under the curve concentration (AUC) for ANAVEX3-71
time frame: 30 days
description: Evaluate AUC for serum concentration of ANAVEX3-71 at specified time points
measure: Effect on ECG, including the ECG QT Interval
time frame: 30 days
description: To characterize the effect on ECG, including the ECG QT Interval for ANAVEX3-71
arm group label: ANAVEX3-71 Oral
arm group type: Experimental
description: Up to four single ascending doses of ANAVEX3-71 administered orally
arm group label: Placebo arm Oral
arm group type: Placebo Comparator
description: Placebo administered orally
intervention type: Drug
intervention name: ANAVEX3-71
description: Active oral dose of ANAVEX3-71
arm group label: ANAVEX3-71 Oral
intervention type: Drug
intervention name: Placebo
description: Oral placebo
arm group label: Placebo arm Oral
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Sponsor
sharing ipd: Undecided