Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.

Nicotine Dependence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700112
• Other study ID #: PROT-00013
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: April 9, 2019

Study information

• Verified date: January 2019
• Source: Juul Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 9, 2019
• Est. primary completion date: February 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Dependence, Cigarettes
• Tobacco Smoking
• Tobacco Use
• Tobacco Use Disorder

Intervention

Other:
• JUUL Virginia Tobacco flavored 5.0% ENDS
Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
• PMI iQOS Heat sticks
PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
• Reynolds VUSE Solo ENDS - Original
Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
• Imperial MyBlu ENDS - Original
Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
• Altria MarkTen ENDS - Bold Classic
Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
• MLV PHIX ENDS - Original Tobacco
MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
• NJOY Daily EXTRA ENDS - Rich Tobacco
NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
• Altria Marlboro combustible cigarette - Red
Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust Ltd	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Juul Labs, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Measure exhaled Carbon Monoxide change in all product administration periods	To estimate change in exhaled carbon monoxide (CO) for 8 E-cigarettes/cigarettes Products, in all product administration periods under 2 different delivery (10 puff and ad-libitum) conditions. Exhaled CO will be measured 5-15 minutes prior to initiation of the first inhalation, and up to 15 minutes after the collection of the 30 minute PK sample	48 days
Secondary	Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale	To characterize measures of subjective effects with use of 8 E-cigarettes/cigarettes Products under 2 different delivery (10 puff and ad-libitum) conditions using a modified Product Evaluations Scale questionnaire using scale below after collection of the 30-minute PK sample and exhaled CO measurement.; Change in Evaluation: 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, 7= extremely; Four multi- item subscales will be derived from "Satisfaction" (questions 1, 2, 3, and 12); "Psychological Reward" (questions 4 through 8); "Aversion" (questions 9, 10, 16, and 18) and "Relief" (questions 11, 13, 14, 15, and reversed for question 19) and single questions 17 and 20 will be summarized.	48 days
Secondary	Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette	To characterize consumptions of 8 E-cigarettes/cigarettes products within-each and between-all delivery conditions (10 puffs versus ad-libitum puffs), by collecting total number of puffs.	48 days