Clinical trial NCT03593239: Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
Official title: A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based Electronic Nicotine Delivery System (ENDS Products), 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: 2018-07-20
Enrollment: 24
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 Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

Detailed description: E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ENDS products.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 60 years of age inclusive.
* Current smoker or e-cigarette user:
* Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

Exclusion criteria:

* 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.
* Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
* Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential.
* Any clinically significant concomitant disease or conditions.

Primary outcomes:
measure: Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)
timeFrame: 38 Days
measure: Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
timeFrame: 38 Days
measure: Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour
timeFrame: 38 Days
measure: Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine
timeFrame: 38 Days
Secondary outcomes:
measure: Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
timeFrame: 38 Days
measure: To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.
timeFrame: 38 Days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust Ltd
Study officials:
affiliation: Christchurch Clinical Studies Trust Ltd
name: Christopher Wynne, MD
role: PRINCIPAL_INVESTIGATOR
References: