<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/NCT03234010</url>
  </required_header>
  <id_info>
    <org_study_id>CSD170303</org_study_id>
    <nct_id>NCT03234010</nct_id>
  </id_info>
  <brief_title>CSD170303: Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes</brief_title>
  <official_title>CSD170303: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAI Services Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Davita Clinical Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>RAI Services Company</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 determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four&#xD;
      different marketed electronic cigarettes. Furthermore, to measure overall product liking by&#xD;
      subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in&#xD;
      the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single-center, randomized, open-label, parallel study during which up to 140&#xD;
      healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled.&#xD;
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The&#xD;
      study will involve the use of four (4) marketed EC products in tobacco consumers who are&#xD;
      exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,&#xD;
      intermittent EC users).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax (Maximum baseline-adjusted nicotine plasma concentration)</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes</time_frame>
    <description>To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCnic0-60</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes</time_frame>
    <description>Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 12, 15 Minutes</time_frame>
    <description>Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCnic0-15</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 12, 15 Minutes</time_frame>
    <description>Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PLoverall</measure>
    <time_frame>13 Minutes</time_frame>
    <description>Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>FT21092 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette FT21092 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT21093 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette FT21093 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT21096 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette FT21096 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT21097 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette FT21097 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT21092</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>FT21092 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT21093</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>FT21093 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT21096</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>FT21096 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT21097</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>FT21097 Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to read, understand, and willing to sign an ICF and complete questionnaires&#xD;
             written in English.&#xD;
&#xD;
          2. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening&#xD;
             Visit.&#xD;
&#xD;
          3. Subjects must meet one (a or b) of the following tobacco use conditions:&#xD;
&#xD;
               1. Exclusive cigarette smoker who self-reports smoking at least (≥) 10 cigarettes&#xD;
                  per day for at least 6 months prior to Screening Visit. Brief periods of&#xD;
                  abstinence more than 30 days prior to screening due to illness, quit attempt or&#xD;
                  clinical study participation will be allowed at the discretion of the&#xD;
                  Investigator.&#xD;
&#xD;
               2. Dual user of combustible cigarettes and electronic cigarettes (EC) who&#xD;
                  self-reports:&#xD;
&#xD;
             i. Smoking at least (≥) 10 cigarettes per day for at least 6 months prior to Screening&#xD;
             Visit. Brief periods of abstinence more than 30 days prior to screening due to&#xD;
             illness, quit attempt or clinical study participation will be allowed at the&#xD;
             discretion of the Investigator and ii. Using a nicotine-containing cig-a-like EC or a&#xD;
             tank system EC either daily or at least weekly for at least 3 months prior to&#xD;
             Screening Visit.&#xD;
&#xD;
          4. Willing to be confined overnight and abstain from tobacco- and nicotine- containing&#xD;
             product use for 12 hours prior to IP use through Study Discharge.&#xD;
&#xD;
          5. Willing to use assigned IP during the study according to protocol.&#xD;
&#xD;
          6. Expired breath carbon monoxide (ECO) level is ≥10 parts per million (ppm) at the&#xD;
             Screening Visit and Study Day 1.&#xD;
&#xD;
          7. Positive urine cotinine test at the Screening Visit and Study Day 1.&#xD;
&#xD;
          8. No intent to quit smoking or vaping from the Screening Visit to Study Day 2.&#xD;
&#xD;
          9. Females must be willing to use a form of contraception acceptable to the Investigator&#xD;
             from the time of signing informed consent until Study Discharge, or be surgically&#xD;
             sterile for at least 90 days prior to the Screening Visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of clinically significant or unstable/uncontrolled acute or chronic medical&#xD;
             conditions at the Screening Visit, as determined by the Investigator, that would&#xD;
             preclude a subject from participating safely in the study (e.g., uncontrolled&#xD;
             hypertension, diabetes, asthma or other lung disease, cardiac disease, neurological&#xD;
             disease or psychiatric disorders) based on safety assessments such as clinical&#xD;
             laboratory tests, pregnancy tests, medical history, and physical/oral examinations.&#xD;
&#xD;
          2. At risk for heart disease, as determined by the Investigator.&#xD;
&#xD;
          3. Systolic blood pressure of &gt; 160 mmHg or a diastolic blood pressure of &gt; 95 mmHg,&#xD;
             measured after being seated for 5 minutes.&#xD;
&#xD;
          4. Weight of ≤ 110 pounds.&#xD;
&#xD;
          5. Poor peripheral venous access.&#xD;
&#xD;
          6. Use of medicine for treatment of depression, unless on a stable dose for the past 6&#xD;
             months prior to screening and deemed clinically stable by the PI.&#xD;
&#xD;
          7. Current scheduled treatment for asthma within the past consecutive 12 months prior to&#xD;
             screening. As needed treatment, such as inhalers, may be included at the PIs&#xD;
             discretion pending approval from the medical monitor.&#xD;
&#xD;
          8. Any history of cancer, except for primary cancers of skin such as localized basal&#xD;
             cell/squamous cell carcinoma that has been surgically and / or cryogenically removed.&#xD;
&#xD;
          9. Use of any medication or substance that aids in smoking cessation, including but not&#xD;
             limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge,&#xD;
             patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract&#xD;
             within 30 days prior to the Screening Visit.&#xD;
&#xD;
         10. History or presence of hemophilia or other bleeding disorders.&#xD;
&#xD;
         11. History or presence of clotting disorders with concomitant use of anticoagulants&#xD;
             (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®] or aspirin [&gt; 325&#xD;
             mg/day]).&#xD;
&#xD;
         12. Participation in another clinical trial within (≤) 30 days prior to the time of&#xD;
             consent. The 30-day window for each subject will be derived from the date of the last&#xD;
             study event in the previous study to the time of consent of the current study.&#xD;
&#xD;
         13. Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen&#xD;
             (HBsAg), or Hepatitis C virus antibody (anti-HCV).&#xD;
&#xD;
         14. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to&#xD;
             become pregnant during the course of the study.&#xD;
&#xD;
         15. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception&#xD;
             or hormone replacement therapy.&#xD;
&#xD;
         16. A positive urine drug screen without disclosure of prescribed corresponding&#xD;
             concomitant medication(s) at the Screening Visit or on Study Day 1.&#xD;
&#xD;
         17. A positive alcohol breathalyzer result at the Screening Visit or on Study Day 1.&#xD;
&#xD;
         18. Employed by a tobacco or nicotine company, the study site, or handles tobacco or&#xD;
             nicotine-containing products as part of their job.&#xD;
&#xD;
         19. Determined by the Investigator to be inappropriate for the study, including a subject&#xD;
             who is unable to communicate or unwilling to cooperate with the clinical staff.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Yoon, MSN, FNP-C</last_name>
    <role>Principal Investigator</role>
    <affiliation>Davita Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DaVita Clinical Research</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</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>


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/NCT03234010
org study id: CSD170303
nct id: NCT03234010
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four
      different marketed electronic cigarettes. Furthermore, to measure overall product liking by
      subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in
      the future.
This will be a single-center, randomized, open-label, parallel study during which up to 140
      healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled.
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The
      study will involve the use of four (4) marketed EC products in tobacco consumers who are
      exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,
      intermittent EC users).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax (Maximum baseline-adjusted nicotine plasma concentration)
time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
description: To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.
measure: AUCnic0-60
time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
description: Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.
measure: Tmax
time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
description: Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.
measure: AUCnic0-15
time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
description: Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.
measure: PLoverall
time frame: 13 Minutes
description: Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.
arm group label: FT21092 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette FT21092 followed by a 2 day in-clinic period.
arm group label: FT21093 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette FT21093 followed by a 2 day in-clinic period.
arm group label: FT21096 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette FT21096 followed by a 2 day in-clinic period.
arm group label: FT21097 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette FT21097 followed by a 2 day in-clinic period.
intervention type: Other
intervention name: FT21092
description: An electronic cigarette
arm group label: FT21092 Group
intervention type: Other
intervention name: FT21093
description: An electronic cigarette
arm group label: FT21093 Group
intervention type: Other
intervention name: FT21096
description: An electronic cigarette
arm group label: FT21096 Group
intervention type: Other
intervention name: FT21097
description: An electronic cigarette
arm group label: FT21097 Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Yoon, MSN, FNP-C
role: Principal Investigator
affiliation: Davita Clinical Research
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No