xml: <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/NCT05979727</url>
    </required_header>
    <id_info>
      <org_study_id>MEO-DMT-VR</org_study_id>
      <nct_id>NCT05979727</nct_id>
    </id_info>
    <brief_title>Dose-finding PKPD Trial for RE02 in Healthy Subjects</brief_title>
    <official_title>Double-blind, Randomized, Dose-response Study of RE02 in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Reconnect Labs</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Reconnect Labs</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>
        The goal of this clinical trial is to compare corresponding inter- and intraindividual&#xD;
        pharmacokinetic and pharmacodynamic profiles including assessments of safety &amp; tolerability&#xD;
        of three different doses against a placebo control.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will undergo a series of four study days with varying doses of RE02 and a&#xD;
        placebo. The intervention is embedded in controlled environment and continuous psychological&#xD;
        support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 6&#xD;
        hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction.&#xD;
        Additionally, the occurrence of adverse events will be closely monitored throughout the whole&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetic parameter &quot;Cmax&quot;</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in Cmax of several doses of RE02</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic parameter &quot;Area under the curve (AUC)&quot;</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in AUC of several doses of RE02.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic parameter &quot;T1/2&quot;</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in T1/2 of several doses of RE02.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events</measure>
      <time_frame>On study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in incidence of adverse drug reactions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood count (Lab biochemistry)</measure>
      <time_frame>Changes from baseline to End of Study, an average of 4 weeks</time_frame>
      <description>Changes from baseline in blood count</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical chemistry (Lab biochemistry)</measure>
      <time_frame>Changes from baseline to End of Study, an average of 4 weeks</time_frame>
      <description>Changes from baseline in any clinical chemistry parameter with potential clinical relevance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood coagulation (Lab biochemistry)</measure>
      <time_frame>Changes from baseline to End of Study, an average of 4 weeks</time_frame>
      <description>Changes from baseline in blood coagulation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>QT interval (12-lead Electrocardiogram [ECG])</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in systolic and diastolic blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in heart rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Temperature</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in temperature</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subjective effects</measure>
      <time_frame>Changes from baseline to study days 1,2,3,4</time_frame>
      <description>Dose-dependent changes in trajectories of subjective effects</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dose of RE02</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Moderate dose of RE02</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>High dose of RE02</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RE02</intervention_name>
      <description>Low, medium or high dose of RE02</description>
      <arm_group_label>High dose of RE02</arm_group_label>
      <arm_group_label>Low dose of RE02</arm_group_label>
      <arm_group_label>Moderate dose of RE02</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Manitol</intervention_name>
      <description>Placebo Comparator</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Willing and capable to give informed consent for the participation in the study after&#xD;
               it has been thoroughly explained&#xD;
  &#xD;
            -  Willing to refrain from drinking alcohol one day before testing days and caffeinated&#xD;
               drinks at the testing days and from consuming psychoactive substances or other&#xD;
               medications for 2 weeks before testing days and for the duration of the study&#xD;
  &#xD;
            -  Already experienced with psychedelic substances (at least 5 prior experiences -&#xD;
               microdoses do not count)&#xD;
  &#xD;
            -  Able and willing to comply with all study requirements&#xD;
  &#xD;
            -  Informed consent form was signed&#xD;
  &#xD;
            -  Good knowledge of the German language&#xD;
  &#xD;
            -  Participant informs study physicians / project scientists about simultaneous treatment&#xD;
               or therapy with other physicians and about current intake of psychotropic substances&#xD;
               or medication&#xD;
  &#xD;
            -  Women of childbearing potential are required to use effective, established&#xD;
               contraception, such as oral, injected or implanted hormonal methods of contraception,&#xD;
               placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier&#xD;
               methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)&#xD;
               with spermicidal foam/gel/film/cream/suppository&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous significant adverse response to a hallucinogenic drug&#xD;
  &#xD;
            -  Participation in another study where pharmaceutical compounds will be given&#xD;
  &#xD;
            -  Presence of Axis I affective, anxiety, or dissociative disorders&#xD;
  &#xD;
            -  Present or antecedent diagnosis of bipolar disorder (I, II, not otherwise specified),&#xD;
               schizophrenia, schizoaffective disorder, psychosis, or other disorders from the&#xD;
               psychotic spectrum&#xD;
  &#xD;
            -  First-degree relatives with present or antecedent schizophrenia, schizoaffective&#xD;
               disorder, or bipolar disorder type I&#xD;
  &#xD;
            -  History of head trauma, seizures, cancer, or cerebrovascular accidents&#xD;
  &#xD;
            -  Recent cardiac or brain surgery&#xD;
  &#xD;
            -  Current abuse of medication or psychotropic substances (including nicotine addiction)&#xD;
               according to SCID I criteria&#xD;
  &#xD;
            -  Presence of major internal or neurological disorders (including sepsis,&#xD;
               pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery&#xD;
               migraine)&#xD;
  &#xD;
            -  Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency,&#xD;
               myocardical infarction, coronary spastic angina)&#xD;
  &#xD;
            -  Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe&#xD;
               arteriosclerosis, thrombophlebitis, Raynaud's disease)&#xD;
  &#xD;
            -  Cerebrovascular disease (e.g., stroke, intracranial bleeding / hemorrhage,&#xD;
               intracranial aneurysm)&#xD;
  &#xD;
            -  Serious abnormalities in ECG or blood count/chemistry&#xD;
  &#xD;
            -  Liver or renal or pulmonary disease&#xD;
  &#xD;
            -  Current use of medications with significant interaction potential with MAOI (e.g.,&#xD;
               antidepressants, antipsychotics, psychostimulants, dopaminergic/serotonergic agents,&#xD;
               anticonvulsants)&#xD;
  &#xD;
            -  high risk of adverse emotional or behavioral reaction based on investigator's clinical&#xD;
               evaluation (e.g., evidence of serious personality disorder, serious current stressors,&#xD;
               lack of social support)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erich Seifritz, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Psychiatry Zurich</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Robin von Rotz</last_name>
      <phone>+41797990831</phone>
      <email>robin@reconnect-labs.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No plan available to date.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979727
  org study id: MEO-DMT-VR
  nct id: NCT05979727
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare corresponding inter- and intraindividual
        pharmacokinetic and pharmacodynamic profiles including assessments of safety & tolerability
        of three different doses against a placebo control.
  Participants will undergo a series of four study days with varying doses of RE02 and a
        placebo. The intervention is embedded in controlled environment and continuous psychological
        support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 6
        hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction.
        Additionally, the occurrence of adverse events will be closely monitored throughout the whole
        study.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Pharmacokinetic parameter "Cmax"
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in Cmax of several doses of RE02
  measure: Pharmacokinetic parameter "Area under the curve (AUC)"
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in AUC of several doses of RE02.
  measure: Pharmacokinetic parameter "T1/2"
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in T1/2 of several doses of RE02.
  measure: Incidence of Treatment-Emergent Adverse Events
  time frame: On study days 1,2,3,4
  description: Dose-dependent changes in incidence of adverse drug reactions
  measure: Blood count (Lab biochemistry)
  time frame: Changes from baseline to End of Study, an average of 4 weeks
  description: Changes from baseline in blood count
  measure: Clinical chemistry (Lab biochemistry)
  time frame: Changes from baseline to End of Study, an average of 4 weeks
  description: Changes from baseline in any clinical chemistry parameter with potential clinical relevance.
  measure: Blood coagulation (Lab biochemistry)
  time frame: Changes from baseline to End of Study, an average of 4 weeks
  description: Changes from baseline in blood coagulation
  measure: QT interval (12-lead Electrocardiogram [ECG])
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)
  measure: Blood pressure
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in systolic and diastolic blood pressure
  measure: Heart rate
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in heart rate
  measure: Temperature
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in temperature
  measure: Subjective effects
  time frame: Changes from baseline to study days 1,2,3,4
  description: Dose-dependent changes in trajectories of subjective effects
  arm group label: Placebo
  arm group type: Placebo Comparator
  arm group label: Low dose of RE02
  arm group type: Active Comparator
  arm group label: Moderate dose of RE02
  arm group type: Active Comparator
  arm group label: High dose of RE02
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: RE02
  description: Low, medium or high dose of RE02
  arm group label: High dose of RE02
  arm group label: Low dose of RE02
  arm group label: Moderate dose of RE02
  intervention type: Drug
  intervention name: Manitol
  description: Placebo Comparator
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erich Seifritz, Prof
  role: Principal Investigator
  affiliation: University Hospital of Psychiatry Zurich
  last name: Robin von Rotz
  phone: +41797990831
  email: robin@reconnect-labs.com
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: No plan available to date.