<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/NCT03807050</url>
  </required_header>
  <id_info>
    <org_study_id>AstaFerm 001</org_study_id>
    <nct_id>NCT03807050</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin</brief_title>
  <official_title>Safety and Pharmacokinetics of Astaxanthin-Rich Carotenoid Extract (AstaFerm™) Administered as a Single Oral Dose to Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NextFerm Technologies LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NextFerm Technologies LTD</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment.&#xD;
      Apart from its coloring ability it is also a strong antioxidative ingredient and contains&#xD;
      health-promoting properties.&#xD;
&#xD;
      Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary&#xD;
      supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12&#xD;
      healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label,&#xD;
      non-randomized, single-dose study. Subjects are admitted to the clinical research center on&#xD;
      the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma&#xD;
      sampling is performed, then they receive a fat balanced breakfast followed by a single&#xD;
      administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived&#xD;
      from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house&#xD;
      (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours&#xD;
      post-dose. Blood for antioxidant activity assessment is also drawn.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 23, 2018</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Estimated to be at 8 to 10 hours after dosing</time_frame>
    <description>The maximum plasma concentration obtained in average of 12 subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-t</measure>
    <time_frame>168 hours after dosing</time_frame>
    <description>Calculate Area under the plasma concentration versus time curve from time =0 h to time of the last measurable concentration of 12 subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time max</measure>
    <time_frame>Estimated to be at 8 to 10 hours after dosing</time_frame>
    <description>Time at which Cmax occurs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>15 days</time_frame>
    <description>Number of subjects that reported incidence of adverse events and details of adverse events that were reported</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Absorption; Chemicals</condition>
  <arm_group>
    <arm_group_label>Astaxanthin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Astaxanthin capsules containing 50 milligram astaxanthin derived from the yeast Phaffia rhodozyma (Xanthophyllomyces dendrorhous)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Astaxanthin</intervention_name>
    <description>Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .</description>
    <arm_group_label>Astaxanthin</arm_group_label>
    <other_name>AstaFerm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers between 18 and &lt;46 years of age.&#xD;
&#xD;
          2. Subjects who provide written informed consent to participate in the study.&#xD;
&#xD;
          3. BMI ranging from 18.0 to &lt;30.0, calculated as Weight (Kg)/Height (m2).&#xD;
&#xD;
          4. Non-smoking (by declaration) for a period of at least 6 months.&#xD;
&#xD;
          5. No known history of significant neurological, renal, cardiovascular (including known&#xD;
             structural cardiac abnormalities or hypertension), respiratory (asthma), endocrine,&#xD;
             gastrointestinal, hepatic or hematopoietic disease, neoplasm, psychiatric or any other&#xD;
             clinically significant medical disorder, which in the investigator's judgment&#xD;
             contraindicate administration of the study medications.&#xD;
&#xD;
          6. No history of drug or alcohol abuse.&#xD;
&#xD;
          7. No known allergy or hypersensitivity to any drug or food.&#xD;
&#xD;
          8. No clinically significant abnormalities in screening physical exam.&#xD;
&#xD;
          9. No clinically significant abnormalities in clinical laboratory parameters (hematology,&#xD;
             biochemistry and urinalysis) at Screening, as determined by the study physicians.&#xD;
&#xD;
         10. Negative HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody tests at&#xD;
             Screening.&#xD;
&#xD;
         11. No significant abnormalities in electrocardiogram.at Screening.&#xD;
&#xD;
         12. Subjects with negative urinary drugs of abuse screen determined at Screening and on&#xD;
             admission to the clinical research center prior to dosing day.&#xD;
&#xD;
         13. Subjects must be able to adhere to the visit schedule and protocol requirements and be&#xD;
             available to complete the study.&#xD;
&#xD;
         14. Subjects must satisfy a medical examiner about their fitness to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with any clinically significant abnormality upon physical examination or in&#xD;
             the clinical laboratory test values.&#xD;
&#xD;
          2. Subjects with a history of clinically defined peptic ulcer or any gastrointestinal&#xD;
             surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder&#xD;
             likely to influence supplement absorption, or with any history of severe&#xD;
             gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.&#xD;
&#xD;
          3. Subjects with significant allergic response to any drug or history of food allergies&#xD;
             deemed clinically significant or exclusionary for the study.&#xD;
&#xD;
          4. Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the&#xD;
             study, or subjects with recent significant change in body weight.&#xD;
&#xD;
          5. Treatment with prescription or over-the-counter drugs, nutraceuticals including&#xD;
             vitamins, herbal medications, food supplements and other prescription drugs not&#xD;
             mentioned above, within 7 days prior to first dosing day.&#xD;
&#xD;
          6. Use of paracetamol (acetaminophen) less than 24 hours before the first dosing day.&#xD;
&#xD;
          7. Subjects who donated blood or received blood or plasma derivatives in the three months&#xD;
             preceding the first study dosing.&#xD;
&#xD;
          8. Participation in another clinical trial with drugs within 3 months prior to first&#xD;
             study dosing day (calculated from the previous study's last dosing date).&#xD;
&#xD;
          9. Subjects with an inability to communicate well with the investigators and Clinical&#xD;
             research Center staff (i.e., language problem, poor mental development or impaired&#xD;
             cerebral function).&#xD;
&#xD;
         10. Subjects that have difficulty fasting or consuming the standard meals that will be&#xD;
             provided.&#xD;
&#xD;
         11. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of&#xD;
             study start, which is considered of significance by the Principal Investigator.&#xD;
&#xD;
         12. Subjects who are non-cooperative or unwilling to sign the consent form.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oren Shibolet, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv Sourasky Medical Center Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <!-- 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/NCT03807050
org study id: AstaFerm 001
nct id: NCT03807050
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment.
      Apart from its coloring ability it is also a strong antioxidative ingredient and contains
      health-promoting properties.

      Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary
      supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12
      healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label,
      non-randomized, single-dose study. Subjects are admitted to the clinical research center on
      the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma
      sampling is performed, then they receive a fat balanced breakfast followed by a single
      administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived
      from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house
      (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours
      post-dose. Blood for antioxidant activity assessment is also drawn.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: Estimated to be at 8 to 10 hours after dosing
description: The maximum plasma concentration obtained in average of 12 subjects
measure: AUC 0-t
time frame: 168 hours after dosing
description: Calculate Area under the plasma concentration versus time curve from time =0 h to time of the last measurable concentration of 12 subjects
measure: Time max
time frame: Estimated to be at 8 to 10 hours after dosing
description: Time at which Cmax occurs
measure: Adverse Events (AEs)
time frame: 15 days
description: Number of subjects that reported incidence of adverse events and details of adverse events that were reported
arm group label: Astaxanthin
arm group type: Experimental
description: Astaxanthin capsules containing 50 milligram astaxanthin derived from the yeast Phaffia rhodozyma (Xanthophyllomyces dendrorhous)
intervention type: Dietary Supplement
intervention name: Astaxanthin
description: Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .
arm group label: Astaxanthin
other name: AstaFerm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Oren Shibolet, Prof.
role: Principal Investigator
affiliation: Tel Aviv Sourasky Medical Center Israel
facility: 
country: Israel
responsible party type: Sponsor