CSD201202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12
CSD201202: A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12
1 other identifier
interventional
36
1 country
1
Brief Summary
This is an open-label, randomized, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedJune 24, 2022
June 1, 2022
1 month
February 4, 2022
June 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
AUC nic 0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use. A relative estimate of nicotine absorption that results from a single use of each of the ENDS IP.
0 to 240 minutes
Cmax
The maximum plasma concentration of nicotine attained over 240 minutes after the start of ENDS IP use.
240 minutes
Study Arms (8)
Product usage order EFDGCHBA
EXPERIMENTALSubjects will use each of the 8 products (EFDGCHBA) during an evaluation period, followed by a 4 hour Test Session
Product usage order HAGBFCED
EXPERIMENTALSubjects will use each of the 8 products (HAGBFCED) during an evaluation period, followed by a 4 hour Test Session
Product usage order CDBEAFHG
EXPERIMENTALSubjects will use each of the 8 products (CDBEAFHG) during an evaluation period, followed by a 4 hour Test Session
Product usage order DECFBGAH
EXPERIMENTALSubjects will use each of the 8 products (DECFBGAH) during an evaluation period, followed by a 4 hour Test Session
Product usage order FGEHDACB
EXPERIMENTALSubjects will use each of the 8 products (FGEHDACB) during an evaluation period, followed by a 4 hour Test Session
Product usage order BCADHEGF
EXPERIMENTALSubjects will use each of the 8 products (BCADHEGF) during an evaluation period, followed by a 4 hour Test Session
Product usage order ABHCGDFE
EXPERIMENTALSubjects will use each of the 8 products (ABHCGDFE) during an evaluation period, followed by a 4 hour Test Session
Product usage order GHFAEBDC
EXPERIMENTALSubjects will use each of the 8 products (GHFAEBDC) during an evaluation period, followed by a 4 hour Test Session
Interventions
P1211216, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1213516, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1213416, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1212716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1213716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1213816, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1211916, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
P1210016, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
Eligibility Criteria
You may qualify if:
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes only combustible filtered, menthol or non-menthol combustible cigarettes (CC), 83 mm to 100 mm in length.
- Agrees to smoke same usual brand (UB) cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
- Subjects must meet one (a or b) of the following tobacco use conditions:
- Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Principal Investigator (PI).
- Dual user of CC and electronic cigarettes (ECs) who self-reports:
- i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, 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 ii. Using a nicotine-containing electronic nicotine delivery system (ENDS) (cartridge or a tank system).
- Willing to use only UB cigarette and ENDS during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
- Agrees to in-clinic confinement of 10 days and 9 nights.
You may not qualify if:
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
- Weight of ≤ 110 pounds.
- Hemoglobin level is \< 12.5 for females or \<13.0 for males g/dL at Screening.
- Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Must not be a current regular user (i.e., \> 5 times per month) of any tobacco products other than CCs or ENDS within the last 6 months prior to screening.
- 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 signing of informed consent.
- History or presence of bleeding or clotting disorders.
- Any use of anticoagulants or daily use of aspirin (≥ 325 mg).
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
- Plasma donation within (≤) 7 days prior to the signing of informed consent and between Screening and check-in Day 1.
- Participation in another clinical trial within (≤) 30 days prior to the signing of informed 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 signing the ICF in the current study.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jason Hong, MD
RAIS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2022
First Posted
February 15, 2022
Study Start
March 14, 2022
Primary Completion
April 15, 2022
Study Completion
April 15, 2022
Last Updated
June 24, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share