A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorRAI Services Company
About this trial
This will be an open-label, randomized, single-site, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters and overall product liking (OPL) following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult combustible cigarette smokers and smokers who also use ENDS products.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening.
Positive urine cotinine test at Screening.
Disqualifiers
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 participant 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 > 95 mmHg, measured after being seated for 5 minutes at Screening and at Check-in Day 1.
Weight of ≤ 110 pounds (≤ 50.0 kg) and body mass index of > 40.0 kg/m2 at Screening.
Trial design
Design model
Crossover
Treatments tested in this trial
Product A
Other interventionMenthol Flavor, 5%
Product B
Other interventionMint Flavor, 5%
Product C
Other interventionTobacco Flavor, 5%
Product D
Other interventionFruit Flavor, 5%
Product E
Other interventionFruit Flavor, 5%
Product F
Other interventionFruit Flavor, 5%
Product G
Other interventionFruit Flavor, 5%
Product H
Other interventionFruit Flavor, 5%
Treatment groups
40 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Product usage order AHBGCFDEExperimental treatment 8 interventions
Group B: Product usage order BACHDGEFExperimental treatment 8 interventions
Group C: Product usage order CBDAEHFGExperimental treatment 8 interventions
Group D: Product usage order DCEBFAGHExperimental treatment 8 interventions
Group E: Product usage order EDFCGBHAExperimental treatment 8 interventions
Group F: Product usage order FEGDHCABExperimental treatment 8 interventions
Group G: Product usage order GFHEADBCExperimental treatment 8 interventions
Group H: Product usage order HGAFBECDExperimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
0 to 240 minutes2
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
Time frame
240 minutesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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