Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
An Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 Puff and Ad-libitum) Conditions, in Healthy Adult Smokers.
1 other identifier
interventional
25
1 country
1
Brief Summary
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
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
September 18, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
December 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2019
CompletedJune 14, 2021
January 1, 2019
3 months
September 18, 2018
June 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
To estimate nicotine pharmacokinetics (PK) profiles across 8 E-Cigarette/cigarette products within-each and between-all delivery conditions (10 puffs versus ad libitum puffs) using Area Under the nicotine concentration-time curve (AUC1hour) calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 60 minutes.
48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using AUC1hour-baseline (baseline adjusted AUC1hour)
48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax (Maximum measured plasma concentration over the duration of the measurement interval.
48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Cmax-baseline(Baseline adjusted Cmax)
48 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
Nicotine Pharmacokinetics (PK) profiles across 8 e-cigarettes/cigarette will be estimated using Tmax(Time of the maximum measured plasma concentration over the duration of the measurement interval. If the maximum value occurs at more than one time point within the time span specified, Tmax is defined as the first time point with this value
48 days
Secondary Outcomes (3)
Measure exhaled Carbon Monoxide change in all product administration periods
48 days
Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
48 days
Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
48 days
Study Arms (8)
JUUL Virginia Tobacco flavored 5.0% ENDS
EXPERIMENTALAdministration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed using 10 puffs delivery method Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed Ad-libitum delivery method
PMI iQOS Heat sticks
EXPERIMENTALAdministration of PMI iQOS Heat sticks - Regular consumed using 10 puffs delivery method Administration of PMI iQOS Heat sticks - Regular consumed ad-libitum delivery method
Reynolds VUSE Solo ENDS - Original
EXPERIMENTALAdministration of Reynolds VUSE Solo ENDS - Original consumed using 10 puffs delivery method Administration of Reynolds VUSE Solo ENDS - Original consumed using ad-libitum delivery method
Imperial MyBlu ENDS - Original
EXPERIMENTALAdministration of Imperial MyBlu ENDS - Original consumed using 10 puffs delivery method Administration of Imperial MyBlu ENDS - Original consumed using ad-libitum delivery method
Altria MarkTen ENDS - Bold Classic
EXPERIMENTALAdministration of Altria MarkTen ENDS - Bold Classic consuming using 10 puffs delivery method Administration of Altria MarkTen ENDS - Bold Classic consuming using ad-libitum delivery method
MLV PHIX ENDS - Original Tobacco
EXPERIMENTALAdministration of MLV PHIX ENDS - Original Tobacco consumed using 10 puffs delivery method Administration of with MLV PHIX ENDS - Original Tobacco consumed using ad-libitum delivery method
NJOY Daily EXTRA ENDS - Rich Tobacco
EXPERIMENTALAdministration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using 10 puffs delivery method Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using delivery method and ad-libitum
Altria Marlboro combustible cigarette - Red
EXPERIMENTALAdministration of Altria Marlboro combustible cigarette - Red consumed using 10 puffs delivery method Administration of Altria Marlboro combustible cigarette - Red consumed using ad-libitum delivery method
Interventions
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
Eligibility Criteria
You may qualify if:
- Male or female aged 18 to 60 years of age inclusive.
- BMI between 18 to 35 kg / m2 inclusive.
- Healthy based on medical history and screening assessments, in the opinion of the Investigator.
- Current smoker of at least 8 cigarettes per day on average.
- Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
- Able to participate, and willing to give written informed consent and comply with study restrictions.
You may not qualify if:
- Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
- Clinically significant abnormality on screening ECG.
- Sustained blood pressure recordings at screening of \< 90 mmHg or \> 150 mmHg for systolic blood pressure, or \< 50 mmHg or \> 90 mmHg for diastolic blood pressure.
- Sustained resting heart rate of \> 100 or \< 40 beats per minute at screening.
- Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
- Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
- Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
- Blood or plasma donation of \> 500 mL within 1 month prior to Assessment Day 1.
- Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juul Labs, Inc.lead
Study Sites (1)
Christchurch Clinical Studies Trust Ltd
Christchurch, 8011, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Concetta Carbonaro
JUUL
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
September 18, 2018
First Posted
October 9, 2018
Study Start
December 4, 2018
Primary Completion
February 24, 2019
Study Completion
April 9, 2019
Last Updated
June 14, 2021
Record last verified: 2019-01