CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Four Different Electronic Cigarettes

• Sponsor: RAI Services Company
• Collaborators: Inflamax Research Incorporated; Davita Clinical Research
• Information provided by (Responsible Party): RAI Services Company

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Smoking	Other: FT21039; Other: FT21041; Other: FT21044; Other: FT21042	Not Applicable

Detailed Description:

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	144 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	CSD170301: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes
Actual Study Start Date :	March 29, 2017
Actual Primary Completion Date :	October 27, 2017
Actual Study Completion Date :	October 27, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: FT21039 Group; 7 day at-home use of electronic cigarette FT21039 followed by a 2 day in-clinic period.	Other: FT21039; An electronic cigarette
Experimental: FT21041 Group; 7 day at-home use of electronic cigarette FT21041 followed by a 2 day in-clinic period.	Other: FT21041; An electronic cigarette
Experimental: FT21044 Group; 7 day at-home use of electronic cigarette FT21044 followed by a 2 day in-clinic period.	Other: FT21044; An electronic cigarette
Experimental: FT21042 Group; 7 day at-home use of electronic cigarette FT21042 followed by a 2 day in-clinic period.	Other: FT21042; An electronic cigarette

Outcome Measures

Primary Outcome Measures :

1. Cmax (Maximum baseline-adjusted nicotine plasma concentration) [ Time Frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes ]
   To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.
2. AUCnic0-60 [ Time Frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes ]
   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.

Secondary Outcome Measures :

1. Tmax and AUCnic0-15 [ Time Frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes ]
   Maximum baseline-adjusted plasma nicotine concentration and area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.
2. PLoverall [ Time Frame: 13 Minutes ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
2. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit.

3. Subjects must meet one (a or b) of the following tobacco use conditions:

   1. Exclusive cigarette smoker who self-reports smoking at least (≥) 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator.
   2. Dual user of combustible cigarettes and ECs who self-reports: 1. Smoking at least (≥) 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator and 2. Using a nicotine-containing cig-a-like EC or a tank system EC either daily or at least weekly for at least 3 months prior to Screening Visit.
4. Willing to be confined overnight and abstain from tobacco- and nicotine- containing product use for 12 hours prior to IP use through Study Discharge.
5. Willing to use assigned IP during the study according to protocol.
6. Expired breath carbon monoxide (ECO) level is ≥10 parts per million (ppm) at the Screening Visit and Study Day 1.
7. Positive urine cotinine test at the Screening Visit and Study Day 1.
8. No intent to quit smoking or vaping from Screening to Study Day 2.
9. Females of childbearing age must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.

Exclusion Criteria:

1. Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the Screening Visit, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, diabetes, asthma or other lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations.
2. At risk for heart disease, as determined by the Investigator.
3. Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥ 95 mmHg, measured after being seated for 5 minutes.
4. Weight of ≤ 110 pounds.
5. Poor peripheral venous access.
6. Use of medicine for treatment of depression or asthma (e.g., paroxetine [Paxil®], montelukast [Singulair®], albuterol [Proventil® HFA]), as deemed clinically significant by the Investigator.
7. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening Visit.
8. History or presence of hemophilia or other bleeding disorders.
9. History or presence of clotting disorders with concomitant use of anticoagulants (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®] and aspirin [> 325 mg/day]).
10. Participation in another clinical trial within (≤) 30 days prior to the time of consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of consent of the current study.
11. Positive test for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibody (anti-HCV).
12. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
13. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
14. A positive urine drug screen without disclosure of corresponding concomitant medication(s) at the Screening Visit or on Study Day 1.
15. A positive alcohol breathalyzer result at Screening Visit or on Study Day 1.
16. Employed by a tobacco or nicotine company, the study site, or handles tobacco or nicotine-containing products as part of their job.
17. Determined by the Investigator to be inappropriate for the study, including a subject who is unable to communicate or unwilling to cooperate with the clinical staff.

Contacts and Locations

Locations

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United States, New Jersey
Inflamax Research, Inc.
Neptune, New Jersey, United States, 07753
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265

Sponsors and Collaborators

RAI Services Company

Inflamax Research Incorporated

Davita Clinical Research

Investigators

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Principal Investigator:	Frank Lee, MD	Inflamax Research Incorporated
Principal Investigator:	Margarita Nunez, MD	High Point Clinical Trial Center

More Information

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Responsible Party:	RAI Services Company
ClinicalTrials.gov Identifier:	NCT03105804 History of Changes
Other Study ID Numbers:	CSD170301
First Posted:	April 10, 2017
Last Update Posted:	April 10, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action