Clinical trial NCT03700112: Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Nicotine Dependence, Cigarettes
Tobacco Use
Tobacco Smoking
Keywords: Electronic Nicotine Delivery System
Combustible Cigarettes
Nicotine
Lead sponsor: Juul Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Detailed description: E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 to 60 years of age inclusive.
2. BMI between 18 to 35 kg / m2 inclusive.
3. Healthy based on medical history and screening assessments, in the opinion of the Investigator.
4. Current smoker of at least 8 cigarettes per day on average.
5. 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.
6. Able to participate, and willing to give written informed consent and comply with study restrictions.

Exclusion Criteria:

1. Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
2. Clinically significant abnormality on screening ECG.
3. 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.
4. Sustained resting heart rate of \> 100 or \< 40 beats per minute at screening.
5. 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.
6. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
7. Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
8. Blood or plasma donation of \> 500 mL within 1 month prior to Assessment Day 1.
9. Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
10. 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.

Primary outcomes:
measure: Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
timeFrame: 48 days
measure: Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
timeFrame: 48 days
measure: Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
timeFrame: 48 days
measure: Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
timeFrame: 48 days
measure: Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
timeFrame: 48 days
Secondary outcomes:
measure: Measure exhaled Carbon Monoxide change in all product administration periods
timeFrame: 48 days
measure: Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale
timeFrame: 48 days
measure: Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette
timeFrame: 48 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust Ltd
Study officials:
affiliation: JUUL
name: Concetta Carbonaro
role: STUDY_DIRECTOR
References: