<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/NCT04461756</url>
  </required_header>
  <id_info>
    <org_study_id>PPP001-Ph1-03</org_study_id>
    <nct_id>NCT04461756</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers</brief_title>
  <official_title>A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tetra Bio-Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Algorithme Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tetra Bio-Pharma</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>
      The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC,&#xD;
      11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.&#xD;
&#xD;
      The secondary objective of this study was to determine the safety and tolerability of THC and&#xD;
      CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">November 24, 2018</completion_date>
  <primary_completion_date type="Actual">November 24, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of adverse events [Safety and Tolerability]</measure>
    <time_frame>over 5 days</time_frame>
    <description>To evaluate treatment-related adverse events of PPP001</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biochemistry test results [Safety and Tolerability]</measure>
    <time_frame>over 5 days</time_frame>
    <description>Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature [Safety and Tolerability]</measure>
    <time_frame>over 5 days</time_frame>
    <description>Oral temperature in Celsius</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse rate [Safety and Tolerability]</measure>
    <time_frame>over 5 days</time_frame>
    <description>Pulse rate (in beats per minute)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure [Safety and Tolerability]</measure>
    <time_frame>over 5 days</time_frame>
    <description>Blood pressure (systolic/diastolic blood pressure in mm Hg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinically significant ECG abnormalities [Safety and Tolerability]</measure>
    <time_frame>over 5 days</time_frame>
    <description>Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)</measure>
    <time_frame>over 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)</measure>
    <time_frame>over 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)</measure>
    <time_frame>over 5 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volonteers</condition>
  <arm_group>
    <arm_group_label>inhaled THC/CBD (PPP001)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PPP001</intervention_name>
    <description>inhalation (vape)</description>
    <arm_group_label>inhaled THC/CBD (PPP001)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index within 21.0 to 32.0 kg/m2, inclusively&#xD;
&#xD;
          -  A light-, non- or ex-smoker of nicotine&#xD;
&#xD;
          -  A history of recreational cannabis use (at least 10 times in the last 5 years)&#xD;
&#xD;
          -  Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1&#xD;
             month before Day 1 of the study&#xD;
&#xD;
          -  Presence of intact oral mucosa&#xD;
&#xD;
          -  Able to follow instructions at the training vaporizing session&#xD;
&#xD;
          -  Clinical laboratory values within the laboratory's stated normal range; if not within&#xD;
             this range, they must have been without clinical significance, as determined by an&#xD;
             investigator&#xD;
&#xD;
          -  No clinically significant diseases captured in the medical history or evidence of&#xD;
             clinically significant findings on the physical examination (including vital signs),&#xD;
             or ECG, as determined by an investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alta sciences</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</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>Marijuana Abuse</mesh_term>
  </condition_browse>
  <!-- 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/NCT04461756
org study id: PPP001-Ph1-03
nct id: NCT04461756
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC,
      11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization.

      The secondary objective of this study was to determine the safety and tolerability of THC and
      CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of adverse events [Safety and Tolerability]
time frame: over 5 days
description: To evaluate treatment-related adverse events of PPP001
measure: Biochemistry test results [Safety and Tolerability]
time frame: over 5 days
description: Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase
measure: Temperature [Safety and Tolerability]
time frame: over 5 days
description: Oral temperature in Celsius
measure: Pulse rate [Safety and Tolerability]
time frame: over 5 days
description: Pulse rate (in beats per minute)
measure: Blood pressure [Safety and Tolerability]
time frame: over 5 days
description: Blood pressure (systolic/diastolic blood pressure in mm Hg)
measure: Clinically significant ECG abnormalities [Safety and Tolerability]
time frame: over 5 days
description: Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)
measure: Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
time frame: over 5 days
measure: Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)
time frame: over 5 days
measure: Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)
time frame: over 5 days
arm group label: inhaled THC/CBD (PPP001)
arm group type: Experimental
intervention type: Drug
intervention name: PPP001
description: inhalation (vape)
arm group label: inhaled THC/CBD (PPP001)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Marijuana Abuse