<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/NCT03822546</url>
  </required_header>
  <id_info>
    <org_study_id>FON-01blu-2018</org_study_id>
    <nct_id>NCT03822546</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations</brief_title>
  <official_title>A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fontem Ventures BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fontem Ventures BV</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two&#xD;
      e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt)&#xD;
      e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label,&#xD;
      cross-over clinical study conducted in 15 healthy US adult smokers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nicotine pharmacokinetics Cmax</measure>
    <time_frame>30 minutes following the start of product use (12 measurements over the period)</time_frame>
    <description>Mean maximum plasma nicotine concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine pharmacokinetics Tmax</measure>
    <time_frame>30 minutes following the start of product use (12 measurements over the period)</time_frame>
    <description>Median time to maximum plasma nicotine concentration (Tmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine pharmacokinetics AUC0-30</measure>
    <time_frame>30 minutes following the start of product use (12 measurements over the period)</time_frame>
    <description>Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective effects questionnaire</measure>
    <time_frame>20 minutes after the start of product use</time_frame>
    <description>Likert-type scale with responses ranging from 1 (not at all) to 7 (extremely). The following questions were asked: Did it make you dizzy? Did it make you nauseous? Did you enjoy it? Did it relieve the urge to smoke? Was it enough nicotine? Was it too much nicotine?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and nature of any adverse events (AE)</measure>
    <time_frame>Through study completion, 6 days</time_frame>
    <description>Incidence and nature of any adverse events (AE) (Safety and Tolerability)</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Conventional cigarette</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subject's preferred brand of commercially available conventional cigarette</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myblu 25 mg freebase</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myblu 16 mg nicotine salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>myblu pod-system containing 16 mg nicotine salt tobacco flavour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myblu 25 mg nicotine salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>myblu pod-system containing 25 mg nicotine salt tobacco flavour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myblu 40 mg nicotine salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>myblu pod-system containing 40 mg nicotine salt tobacco flavour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>blu PRO 48 mg nicotine salt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>blu PRO open-system containing 48 mg nicotine salt tobacco flavour</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional cigarette</intervention_name>
    <description>Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals</description>
    <arm_group_label>Conventional cigarette</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>myblu 25 mg freebase</intervention_name>
    <description>E-cigarette used for 10 inhalations every 30 seconds</description>
    <arm_group_label>myblu 25 mg freebase</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>myblu 16 mg nicotine salt</intervention_name>
    <description>E-cigarette used for 10 inhalations every 30 seconds</description>
    <arm_group_label>myblu 16 mg nicotine salt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>myblu 25 mg nicotine salt</intervention_name>
    <description>E-cigarette used for 10 inhalations every 30 seconds</description>
    <arm_group_label>myblu 25 mg nicotine salt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>myblu 40 mg nicotine salt</intervention_name>
    <description>E-cigarette used for 10 inhalations every 30 seconds</description>
    <arm_group_label>myblu 40 mg nicotine salt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blu PRO 48 mg nicotine salt</intervention_name>
    <description>E-cigarette used for 10 inhalations every 30 seconds</description>
    <arm_group_label>blu PRO 48 mg nicotine salt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having smoked ≥10 manufactured cigarettes per day for at least the last year&#xD;
&#xD;
          -  Expired carbon monoxide level of &gt;10 ppm at screening&#xD;
&#xD;
          -  Tested positive for urinary cotinine (≥500 ng/mL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected hypersensitivity to any component of the e-liquid formulations&#xD;
&#xD;
          -  Taking or receiving prescription smoking cessation medicines&#xD;
&#xD;
          -  Willing or considering to stop smoking&#xD;
&#xD;
          -  Smokers who draw smoke into their mouth and throat but do not inhale&#xD;
&#xD;
          -  Relevant illness history&#xD;
&#xD;
          -  Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2&#xD;
&#xD;
          -  Breastfeeding women&#xD;
&#xD;
          -  Women of child-bearing potential who were not using an accepted method of&#xD;
             contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03822546
org study id: FON-01blu-2018
nct id: NCT03822546
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two
      e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt)
      e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label,
      cross-over clinical study conducted in 15 healthy US adult smokers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Nicotine pharmacokinetics Cmax
time frame: 30 minutes following the start of product use (12 measurements over the period)
description: Mean maximum plasma nicotine concentration (Cmax)
measure: Nicotine pharmacokinetics Tmax
time frame: 30 minutes following the start of product use (12 measurements over the period)
description: Median time to maximum plasma nicotine concentration (Tmax)
measure: Nicotine pharmacokinetics AUC0-30
time frame: 30 minutes following the start of product use (12 measurements over the period)
description: Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)
measure: Subjective effects questionnaire
time frame: 20 minutes after the start of product use
description: Likert-type scale with responses ranging from 1 (not at all) to 7 (extremely). The following questions were asked: Did it make you dizzy? Did it make you nauseous? Did you enjoy it? Did it relieve the urge to smoke? Was it enough nicotine? Was it too much nicotine?
measure: Incidence and nature of any adverse events (AE)
time frame: Through study completion, 6 days
description: Incidence and nature of any adverse events (AE) (Safety and Tolerability)
arm group label: Conventional cigarette
arm group type: Experimental
description: The subject's preferred brand of commercially available conventional cigarette
arm group label: myblu 25 mg freebase
arm group type: Active Comparator
description: myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour
arm group label: myblu 16 mg nicotine salt
arm group type: Active Comparator
description: myblu pod-system containing 16 mg nicotine salt tobacco flavour
arm group label: myblu 25 mg nicotine salt
arm group type: Active Comparator
description: myblu pod-system containing 25 mg nicotine salt tobacco flavour
arm group label: myblu 40 mg nicotine salt
arm group type: Active Comparator
description: myblu pod-system containing 40 mg nicotine salt tobacco flavour
arm group label: blu PRO 48 mg nicotine salt
arm group type: Active Comparator
description: blu PRO open-system containing 48 mg nicotine salt tobacco flavour
intervention type: Other
intervention name: Conventional cigarette
description: Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
arm group label: Conventional cigarette
intervention type: Other
intervention name: myblu 25 mg freebase
description: E-cigarette used for 10 inhalations every 30 seconds
arm group label: myblu 25 mg freebase
intervention type: Other
intervention name: myblu 16 mg nicotine salt
description: E-cigarette used for 10 inhalations every 30 seconds
arm group label: myblu 16 mg nicotine salt
intervention type: Other
intervention name: myblu 25 mg nicotine salt
description: E-cigarette used for 10 inhalations every 30 seconds
arm group label: myblu 25 mg nicotine salt
intervention type: Other
intervention name: myblu 40 mg nicotine salt
description: E-cigarette used for 10 inhalations every 30 seconds
arm group label: myblu 40 mg nicotine salt
intervention type: Other
intervention name: blu PRO 48 mg nicotine salt
description: E-cigarette used for 10 inhalations every 30 seconds
arm group label: blu PRO 48 mg nicotine salt
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine
sharing ipd: No