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/NCT06017219</url>
    </required_header>
    <id_info>
      <org_study_id>AFCRO 167</org_study_id>
      <nct_id>NCT06017219</nct_id>
    </id_info>
    <brief_title>Bioavailability of Spermidine in Healthy Males</brief_title>
    <official_title>Bioavailability of Spermidine in Healthy Males</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chrysea Labs Lda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chrysea Labs Lda</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>
        To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence&#xD;
        of any Adverse Events/Serious adverse events.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Until now, lack of availability of a reproducible high quality, uncontaminated, spermidine&#xD;
        for human consumption as a food or supplement has been a significant barrier to its study and&#xD;
        use.&#xD;
  &#xD;
        Chrysea is producing spermidine by a patented biological process to consistently produce very&#xD;
        high purity spermidine to pharmaceutical and food grade standards.&#xD;
  &#xD;
        Using a rat ex vivo jejunal absorption model and 14Carbon labelled spermidine, the recovery&#xD;
        rate of radioactivity at the portal vein was approximately 61-76% during the initial 10&#xD;
        minutes after the administration of 14C-spermidine.&#xD;
  &#xD;
        Data on spermidine absorption in humans is very limited. The purpose of this single blind&#xD;
        randomised pharmacokinetic study is to demonstrate absorption of 20mg and 40 mg doses of&#xD;
        spermidine in fasted normal volunteers, and to describe the absorption kinetics (Tmax, Cmax,&#xD;
        T1/2, AUC).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 5, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>single blind cross over study</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>single blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males</measure>
      <time_frame>Pre dosing to dosing plus six hours</time_frame>
      <description>Maximum concentration of circulating spermidine (Cmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males</measure>
      <time_frame>Pre dosing to dosing plus six hours</time_frame>
      <description>Time to peak of circulating spermidine (Tmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.</measure>
      <time_frame>Pre dosing to dosing plus six hours</time_frame>
      <description>Half-life of circulating spermidine (t1/2)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males</measure>
      <time_frame>Pre dosing to dosing plus six hours</time_frame>
      <description>Area Under the Curve (AUC)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Healthy Subjects</condition>
    <arm_group>
      <arm_group_label>within subject control 20mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>spermidine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>within subject control 40mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>spermidine</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>spermidine</intervention_name>
      <description>spermidine</description>
      <arm_group_label>within subject control 20mg</arm_group_label>
      <arm_group_label>within subject control 40mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to give written informed consent.&#xD;
  &#xD;
            -  Male.&#xD;
  &#xD;
            -  Age between 18-70 years inclusive.&#xD;
  &#xD;
            -  BMI between ≥18.5 and ≤28 kg/m2.&#xD;
  &#xD;
            -  In general good health, as determined by the investigator.&#xD;
  &#xD;
            -  Agree to abstain from consuming alcohol, grapefruit, or grapefruit juice for 72 hours&#xD;
               prior to visit 2 and visit 3.&#xD;
  &#xD;
            -  Adequate vein access for cannulation and multiple blood draws.&#xD;
  &#xD;
            -  Able to communicate well with the Investigator, to understand and comply with the&#xD;
               requirements of the study and be judged suitable for the study in the opinion of the&#xD;
               Investigator.&#xD;
  &#xD;
            -  Willing to consume the study product.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of anaphylaxis,&#xD;
  &#xD;
            -  Documented hypersensitivity reaction or a clinically important reaction to any&#xD;
               dietary/food supplement or drug,&#xD;
  &#xD;
            -  Intolerance or sensitivity to study product ingredients&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dr Patrick Keohane</last_name>
      <role>Study Director</role>
      <affiliation>Chrysea Labs</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork</name>
        <address>
          <city>Cork</city>
          <country>Ireland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <reference>
      <citation>Uda K, Tsujikawa T, Fujiyama Y, Bamba T. Rapid absorption of luminal polyamines in a rat small intestine ex vivo model. J Gastroenterol Hepatol. 2003 May;18(5):554-9. doi: 10.1046/j.1440-1746.2003.03020.x.</citation>
      <PMID>12702048</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06017219
  org study id: AFCRO 167
  nct id: NCT06017219
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence
        of any Adverse Events/Serious adverse events.
  Until now, lack of availability of a reproducible high quality, uncontaminated, spermidine
        for human consumption as a food or supplement has been a significant barrier to its study and
        use.
  
        Chrysea is producing spermidine by a patented biological process to consistently produce very
        high purity spermidine to pharmaceutical and food grade standards.
  
        Using a rat ex vivo jejunal absorption model and 14Carbon labelled spermidine, the recovery
        rate of radioactivity at the portal vein was approximately 61-76% during the initial 10
        minutes after the administration of 14C-spermidine.
  
        Data on spermidine absorption in humans is very limited. The purpose of this single blind
        randomised pharmacokinetic study is to demonstrate absorption of 20mg and 40 mg doses of
        spermidine in fasted normal volunteers, and to describe the absorption kinetics (Tmax, Cmax,
        T1/2, AUC).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: single blind cross over study
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: single blind
  measure: Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
  time frame: Pre dosing to dosing plus six hours
  description: Maximum concentration of circulating spermidine (Cmax)
  measure: Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
  time frame: Pre dosing to dosing plus six hours
  description: Time to peak of circulating spermidine (Tmax)
  measure: T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.
  time frame: Pre dosing to dosing plus six hours
  description: Half-life of circulating spermidine (t1/2)
  measure: AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males
  time frame: Pre dosing to dosing plus six hours
  description: Area Under the Curve (AUC)
  arm group label: within subject control 20mg
  arm group type: Experimental
  description: spermidine
  arm group label: within subject control 40mg
  arm group type: Experimental
  description: spermidine
  intervention type: Dietary Supplement
  intervention name: spermidine
  description: spermidine
  arm group label: within subject control 20mg
  arm group label: within subject control 40mg
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dr Patrick Keohane
  role: Study Director
  affiliation: Chrysea Labs
  facility: 
  country: Ireland
  citation: Uda K, Tsujikawa T, Fujiyama Y, Bamba T. Rapid absorption of luminal polyamines in a rat small intestine ex vivo model. J Gastroenterol Hepatol. 2003 May;18(5):554-9. doi: 10.1046/j.1440-1746.2003.03020.x.
  PMID: 12702048
  responsible party type: Sponsor
  sharing ipd: No