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/NCT06035900</url>
    </required_header>
    <id_info>
      <org_study_id>PSIL22060</org_study_id>
      <nct_id>NCT06035900</nct_id>
    </id_info>
    <brief_title>Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate</brief_title>
    <acronym>Psilocin-1</acronym>
    <official_title>Phase 1, Open-Label, One-Treatment, Single-Dose, One-Period, Pharmacokinetic Study of Psilocin 4 mg as Its Mucic Acid Salt (L-130) Form, in Healthy Subjects Under Fasted Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lobe Sciences Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pharmaceutical Research Unit, Jordan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Lobe Sciences Ltd.</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>
        Psilocin is the active metabolite of psilocybin a natural material found in several types of&#xD;
        fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be&#xD;
        over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been&#xD;
        reported. This Phase I &quot;First in Man&quot; study of psilocin mucate is designed to determine its&#xD;
        safety, pharmacokinetics, and bioavailability. The study is conducted under the supervision&#xD;
        of physicians and psychiatrists who also will administer a mini-mental state evaluation and&#xD;
        report observable anti-anxiolytic effect of the dosage. Safety and possible indications of&#xD;
        efficacy will be tracked during the study period, a week following the dose administration&#xD;
        and one month after.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is designed to assess the bioavailability and pharmacokinetic parameters and to&#xD;
        monitor the safety and tolerability of Psilocin 2 mg as its Mucic Acid Salt (L-130) form, a&#xD;
        proprietary drug candidate of Lobe Sciences Ltd., in healthy subjects under fasted&#xD;
        conditions.&#xD;
  &#xD;
        The study will be conducted in compliance with the protocol and applicable regulatory&#xD;
        requirements, GCP and GLP principles and guidelines: Declaration of Helsinki as amended by&#xD;
        the 64th WMA General Assembly, Fortaleza, Brazil, November 2013, FDA Guidelines for&#xD;
        Bioavailability &amp; Bioequivalence Studies and OECD Principles of Good Laboratory Practice will&#xD;
        be observed.&#xD;
  &#xD;
        The study population will consist of 10 Healthy Subjects aged between 21 and 50 years&#xD;
        (inclusive), body mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight for males&#xD;
        and 45 kg for females), nonsmokers or quit smoking 24 hours prior to dosing.&#xD;
  &#xD;
        The investigational test product L-130 Capsules containing 2 mg of psilocin as its Mucic Acid&#xD;
        Salt of Lobe Sciences Ltd. consisted of single oral dose containing 2 mg of Psilocin&#xD;
        (equivalent to 4 mg as Psilocin Mucate salt).&#xD;
  &#xD;
        Each dose will be administered orally, with 240 mL of water in sitting position under sodium&#xD;
        light to healthy subjects after an overnight fast of at least 10 hours in the morning of&#xD;
        study dosing day. The study will be conducted as an open label study. Therefore, blinding&#xD;
        will not be done. However, the bioanalysis will be performed blinded with regard to the&#xD;
        sequence of product administration. Each subject will have a pre-dose sample of 8 ml&#xD;
        collected and 13 additional 8 ml samples collected over a 24 hour period.&#xD;
  &#xD;
        The principal and/ or clinical investigator and study staff will monitor subjects throughout&#xD;
        the hospitalization periods. Blood pressure and heart rate will be measured before dosing and&#xD;
        at scheduled intervals after dosing. The principal and/ or clinical Investigator will be&#xD;
        available throughout each hospitalization period. During outpatient phases, study staff will&#xD;
        be available during regular working hours.&#xD;
  &#xD;
        Subjects' safety will be observed at scheduled intervals of before dosing (-1.00) and 0.50,&#xD;
        0.75, 1.00, 2.00, 3.00, 5.00, 8.00, 12.00, 16.00 and 24.00 hours after drug administration.&#xD;
        Subjects will be queried on adverse events. In addition, voluntary reporting of adverse&#xD;
        events by subjects will be reported.&#xD;
  &#xD;
        Mini Mental State Examination (MMSE) score will be assessed to dosed subjects by CI/PI&#xD;
        approximately two hours after drug administration, and the results will be tabulated in the&#xD;
        final report. Subjects will be asked to report changes in their mood, or other observations&#xD;
        during and following the study period. Subjects will also be followed up by phone call after&#xD;
        one week and four weeks of dosing to assess if they are experiencing changes in feeling or&#xD;
        having improved mood, and the outcomes of the phone calls will be tabulated in the final&#xD;
        report.&#xD;
  &#xD;
        Following the collection of blood samples and appropriate processing, each sample will be&#xD;
        analyzed with a validated analytical method to determine the pharmacokinetic profile of&#xD;
        psilocin mucate in plasma.&#xD;
  &#xD;
        All clinical laboratories test results of screening lab tests will be summarized by&#xD;
        descriptive statistics. Follow up lab tests will also be summarized by descriptive&#xD;
        statistics.&#xD;
  &#xD;
        The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to&#xD;
        monitor the safety and tolerability of the formulation in healthy subjects under fasting&#xD;
        conditions after a single oral dose of L-130 Capsules containing 2 mg of psilocin as its&#xD;
        Mucic Acid Salt. The final report will provide safety, tolerability and pharmacokinetics of&#xD;
        the test product. The study will also report patient reported pharmacology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to monitor the safety and tolerability of a formulation in healthy subjects under fasting conditions after a single oral dose of L-130 Capsules containing 2 mg of psilocin as its Mucic Acid Salt or Conjugate.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determination of adverse events</measure>
      <time_frame>28 days</time_frame>
      <description>Frequency</description>
    </primary_outcome>
    <other_outcome>
      <measure>Plasma Concentration (Cmax)</measure>
      <time_frame>24 hours</time_frame>
      <description>nanograms/milliliter (ng/ml)</description>
    </other_outcome>
    <other_outcome>
      <measure>Area Under the plasma concentration versus time curve (AUC)</measure>
      <time_frame>24 hours</time_frame>
      <description>nanograms minute/milliliter (ng min/ml)</description>
    </other_outcome>
    <other_outcome>
      <measure>Time to maximum plasma concentration (Tmax)</measure>
      <time_frame>24 hours</time_frame>
      <description>minutes</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Side Effect of Drug</condition>
    <arm_group>
      <arm_group_label>10 normal healthy male volunteers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 normal healthy male volunteers where each subject was given an identification code after signing the informed consent which was obtained according to APIC/PRU procedure of obtaining Consent form. The identification code consisted of the subject's initials, and a serial number.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Psilocin</intervention_name>
      <description>single 4mg dose of psilocin mucate was administered to healthy 10 volunteers</description>
      <arm_group_label>10 normal healthy male volunteers</arm_group_label>
      <other_name>Psilocin Mucate</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age 21-50 years. Body-mass index 18.5 to 30.0 kg/m2 inclusive. (Minimum of 50 kg weight for&#xD;
          males and 45 kg for females).&#xD;
  &#xD;
          Subject is available for the whole study period and gave written informed consent.&#xD;
  &#xD;
          Normal physical examination or being assessed as clinically non-significant by the&#xD;
          attending physician.&#xD;
  &#xD;
          Normal neurological, cardiovascular, cerebrovascular, gastrointestinal and respiratory&#xD;
          systems.&#xD;
  &#xD;
          Normal Vital Signs. Normal Electrocardiogram (ECG). Subjects refraining from alcohol use,&#xD;
          other study medication and drugs.&#xD;
  &#xD;
          Lab test inclusion criteria:&#xD;
  &#xD;
          On Screening Chemistry, Hematology and Urine laboratory screening results within the normal&#xD;
          range, or being assessed as clinically non-significant by the attending physician.&#xD;
  &#xD;
          Normal Liver and kidney function test.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Lab test exclusion criteria&#xD;
  &#xD;
          On screening&#xD;
  &#xD;
            1. Positive serology test.&#xD;
  &#xD;
            2. Chemistry, Haematology and Urine laboratory screening results not within the normal&#xD;
               range, or being assessed as clinically significant by the attending physician&#xD;
  &#xD;
            3. Abnormal Liver and kidney function test.&#xD;
  &#xD;
            4. Positive hCG for female subjects.&#xD;
  &#xD;
          On Admission:&#xD;
  &#xD;
            1. The intake of caffeine, xanthene, or CO2-containing beverages within 24 hours of drug&#xD;
               administration.&#xD;
  &#xD;
            2. Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of&#xD;
               drug administration&#xD;
  &#xD;
            3. Ingestion of any supplements like vitamins or herbal products within 7 days prior to&#xD;
               each drug administration study.&#xD;
  &#xD;
            4. Clinically significant illness 4 weeks before study Period I&#xD;
  &#xD;
            5. Exhausting physical exercise in the last 24 hours (e.g. weight lifting) or any recent&#xD;
               significant change in dietary or exercise habits.&#xD;
  &#xD;
            6. Abnormal vital signs and being assessed as clinically significant.&#xD;
  &#xD;
            7. Vomiting, diarrhea on admission.&#xD;
  &#xD;
            8. Subjects with concurrent medication must be taken 14 days before drug administration&#xD;
               and during study period especially warfarin, aspirin, non-steroidal anti-inflammatory&#xD;
               drugs, levodopa, antipsychotic medicinal products, fibrates, ciclosporin, fusidic acid&#xD;
               (a medicine for bacterial infection), orally and or by injection.&#xD;
  &#xD;
            9. Participation in another bioequivalence study and/or clinical trials within 80 days&#xD;
               prior to the start of this study Period.&#xD;
  &#xD;
           10. Have been taking medication that could affect the investigated drug product: a)&#xD;
               Regular consumption of drugs during the b) consumption of enzyme stimulating or&#xD;
               inhibiting drugs (e.g.&#xD;
  &#xD;
               Barbiturates, Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid,&#xD;
               cocaine, opiates, phencyclidine and methadone) during two weeks before the study&#xD;
               initiation.&#xD;
  &#xD;
           11. Subject taking medications that belongs to strong CYP3A4 inhibitors (including, but&#xD;
               not limited to, ketoconazole, itraconazole, voriconazole, clarithromycin,&#xD;
               telithromycin, ritonavir) or inducers (e.g., phenytoin, rifampicin, carbamazepine,&#xD;
               phenobarbital and St. John's Wort) within 4 weeks prior to study.&#xD;
  &#xD;
           12. Subject taking monoamine oxidase inhibitors medications.&#xD;
  &#xD;
           13. Subject taking selective serotonin reuptake inhibitor/serotonin-norepinephrine&#xD;
               reuptake inhibitors (SSRI/SNRI) medications.&#xD;
  &#xD;
           14. Subject taking uridine diphosphate glucuronosyl transferase enzyme modulators&#xD;
               medication.&#xD;
  &#xD;
          Pre-dose:&#xD;
  &#xD;
            1. Pre-dosing blood pressure less than 110/70 mmHg.&#xD;
  &#xD;
            2. Pre-dosing heart rate less than 70 beats per minute.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmad Abdulkhaleq, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Arab Pharmaceutical Industry Pharmaceutical Research</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pharmaceutical Research Unit</name>
        <address>
          <city>Amman</city>
          <zip>11910</zip>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Drug-Related Side Effects and Adverse Reactions</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psilocin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to share the bioavailability data and pharmacokinetics of psilocin mucate in a peer reviewed publication. We also plan to share safety information gathered during the Phase 1 segment of the trial also in a separate publication in a peer reviewed journal.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>We hope to complete the trial and receive a final report that will be the source of at least two publications in or around March 2024.</ipd_time_frame>
      <ipd_access_criteria>We plan to share the data from the pharmacokinetics study with any academic research or medical institution upon written request to the Project Leader and Central Contact Person: Dr. Fred D. Sancilio</ipd_access_criteria>
    </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/NCT06035900
  org study id: PSIL22060
  nct id: NCT06035900
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Psilocin is the active metabolite of psilocybin a natural material found in several types of
        fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be
        over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been
        reported. This Phase I "First in Man" study of psilocin mucate is designed to determine its
        safety, pharmacokinetics, and bioavailability. The study is conducted under the supervision
        of physicians and psychiatrists who also will administer a mini-mental state evaluation and
        report observable anti-anxiolytic effect of the dosage. Safety and possible indications of
        efficacy will be tracked during the study period, a week following the dose administration
        and one month after.
  This study is designed to assess the bioavailability and pharmacokinetic parameters and to
        monitor the safety and tolerability of Psilocin 2 mg as its Mucic Acid Salt (L-130) form, a
        proprietary drug candidate of Lobe Sciences Ltd., in healthy subjects under fasted
        conditions.
  
        The study will be conducted in compliance with the protocol and applicable regulatory
        requirements, GCP and GLP principles and guidelines: Declaration of Helsinki as amended by
        the 64th WMA General Assembly, Fortaleza, Brazil, November 2013, FDA Guidelines for
        Bioavailability & Bioequivalence Studies and OECD Principles of Good Laboratory Practice will
        be observed.
  
        The study population will consist of 10 Healthy Subjects aged between 21 and 50 years
        (inclusive), body mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight for males
        and 45 kg for females), nonsmokers or quit smoking 24 hours prior to dosing.
  
        The investigational test product L-130 Capsules containing 2 mg of psilocin as its Mucic Acid
        Salt of Lobe Sciences Ltd. consisted of single oral dose containing 2 mg of Psilocin
        (equivalent to 4 mg as Psilocin Mucate salt).
  
        Each dose will be administered orally, with 240 mL of water in sitting position under sodium
        light to healthy subjects after an overnight fast of at least 10 hours in the morning of
        study dosing day. The study will be conducted as an open label study. Therefore, blinding
        will not be done. However, the bioanalysis will be performed blinded with regard to the
        sequence of product administration. Each subject will have a pre-dose sample of 8 ml
        collected and 13 additional 8 ml samples collected over a 24 hour period.
  
        The principal and/ or clinical investigator and study staff will monitor subjects throughout
        the hospitalization periods. Blood pressure and heart rate will be measured before dosing and
        at scheduled intervals after dosing. The principal and/ or clinical Investigator will be
        available throughout each hospitalization period. During outpatient phases, study staff will
        be available during regular working hours.
  
        Subjects' safety will be observed at scheduled intervals of before dosing (-1.00) and 0.50,
        0.75, 1.00, 2.00, 3.00, 5.00, 8.00, 12.00, 16.00 and 24.00 hours after drug administration.
        Subjects will be queried on adverse events. In addition, voluntary reporting of adverse
        events by subjects will be reported.
  
        Mini Mental State Examination (MMSE) score will be assessed to dosed subjects by CI/PI
        approximately two hours after drug administration, and the results will be tabulated in the
        final report. Subjects will be asked to report changes in their mood, or other observations
        during and following the study period. Subjects will also be followed up by phone call after
        one week and four weeks of dosing to assess if they are experiencing changes in feeling or
        having improved mood, and the outcomes of the phone calls will be tabulated in the final
        report.
  
        Following the collection of blood samples and appropriate processing, each sample will be
        analyzed with a validated analytical method to determine the pharmacokinetic profile of
        psilocin mucate in plasma.
  
        All clinical laboratories test results of screening lab tests will be summarized by
        descriptive statistics. Follow up lab tests will also be summarized by descriptive
        statistics.
  
        The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to
        monitor the safety and tolerability of the formulation in healthy subjects under fasting
        conditions after a single oral dose of L-130 Capsules containing 2 mg of psilocin as its
        Mucic Acid Salt. The final report will provide safety, tolerability and pharmacokinetics of
        the test product. The study will also report patient reported pharmacology.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to monitor the safety and tolerability of a formulation in healthy subjects under fasting conditions after a single oral dose of L-130 Capsules containing 2 mg of psilocin as its Mucic Acid Salt or Conjugate.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Determination of adverse events
  time frame: 28 days
  description: Frequency
  measure: Plasma Concentration (Cmax)
  time frame: 24 hours
  description: nanograms/milliliter (ng/ml)
  measure: Area Under the plasma concentration versus time curve (AUC)
  time frame: 24 hours
  description: nanograms minute/milliliter (ng min/ml)
  measure: Time to maximum plasma concentration (Tmax)
  time frame: 24 hours
  description: minutes
  arm group label: 10 normal healthy male volunteers
  arm group type: Experimental
  description: 10 normal healthy male volunteers where each subject was given an identification code after signing the informed consent which was obtained according to APIC/PRU procedure of obtaining Consent form. The identification code consisted of the subject's initials, and a serial number.
  intervention type: Drug
  intervention name: Psilocin
  description: single 4mg dose of psilocin mucate was administered to healthy 10 volunteers
  arm group label: 10 normal healthy male volunteers
  other name: Psilocin Mucate
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 21 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmad Abdulkhaleq, MD
  role: Principal Investigator
  affiliation: Arab Pharmaceutical Industry Pharmaceutical Research
  facility: 
  country: Jordan
  responsible party type: Sponsor
  mesh term: Drug-Related Side Effects and Adverse Reactions
  mesh term: Psilocin
  sharing ipd: Yes
  ipd description: We plan to share the bioavailability data and pharmacokinetics of psilocin mucate in a peer reviewed publication. We also plan to share safety information gathered during the Phase 1 segment of the trial also in a separate publication in a peer reviewed journal.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: We hope to complete the trial and receive a final report that will be the source of at least two publications in or around March 2024.
  ipd access criteria: We plan to share the data from the pharmacokinetics study with any academic research or medical institution upon written request to the Project Leader and Central Contact Person: Dr. Fred D. Sancilio