CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
CSD210202: An Unblinded, Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
1 other identifier
interventional
33
1 country
1
Brief Summary
This is an open-label, randomized, 5-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.
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 Feb 2021
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 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedJune 24, 2022
June 1, 2022
2 months
February 8, 2021
June 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
AUCnic0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
0 to 240 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
240 minutes
Study Arms (10)
Product usage order ABECD
EXPERIMENTALSubjects will use each of the 5 products (ABECD) during an evaluation period, followed by a 4 hour Test Session
Product usage order BCADE
EXPERIMENTALSubjects will use each of the 5 products (BCADE) during an evaluation period, followed by a 4 hour Test Session
Product usage order CDBEA
EXPERIMENTALSubjects will use each of the 5 products (CDBEA) during an evaluation period, followed by a 4 hour Test Session
Product usage order DECAB
EXPERIMENTALSubjects will use each of the 5 products (DECAB) during an evaluation period, followed by a 4 hour Test Session
Product usage order EADBC
EXPERIMENTALSubjects will use each of the 5 products (EADBC) during an evaluation period, followed by a 4 hour Test Session
Product usage order DCEBA
EXPERIMENTALSubjects will use each of the 5 products (DCEBA) during an evaluation period, followed by a 4 hour Test Session
Product usage order EDACB
EXPERIMENTALSubjects will use each of the 5 products (EDACB) during an evaluation period, followed by a 4 hour Test Session
Product usage order AEBDC
EXPERIMENTALSubjects will use each of the 5 products (AEBDC) during an evaluation period, followed by a 4 hour Test Session
Product usage order BACED
EXPERIMENTALSubjects will use each of the 5 products (BACED) during an evaluation period, followed by a 4 hour Test Session
Product usage order CBDAE
EXPERIMENTALSubjects will use each of the 5 products (CBDAE) during an evaluation period, followed by a 4 hour Test Session
Interventions
P0213420, a 1.8% nicotine ENDS product
P0213520, a 1.8% nicotine ENDS product
P0211220, a 1.8% nicotine ENDS product
P0211820, a 1.8% nicotine ENDS product
P0213417, a 2.4% nicotine ENDS product
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 filtered, menthol or non-menthol combustible cigarettes, 83 mm to 100 mm in length.
- Agrees to smoke same UB combustible cigarette throughout the study period. UB combustible cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
- 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).
- Willing to use only UB combustible 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 7 days and 6 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.
- 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.
- Use of an ENDS or tobacco or nicotine-containing products other than cigarettes (e.g., lozenges, moist snuff) within (≤) 30 days prior to Screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any 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 aspirin (≥ 325 mg/day).
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent.
- Plasma donation within (≤) 7 days prior to the signing of informed consent.
- Plans to donate whole blood or plasma prior to Enrollment and Study Day 1.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AMR Knoxville
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Interventions
Condition 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 8, 2021
First Posted
February 12, 2021
Study Start
February 23, 2021
Primary Completion
April 20, 2021
Study Completion
April 20, 2021
Last Updated
June 24, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share