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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Juul Labs, Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Crème brulee flavored JUUL 5% ENDS
Crème brulee flavored JUUL 5% ENDS (10 puffs)
Intervention: Crème brulee flavored JUUL 5% ENDS (Other)
Mint flavored JUUL 5% ENDS
Mint flavored JUUL 5% ENDS (10 puffs)
Intervention: Mint flavored JUUL 5% ENDS (Other)
Tobacco flavored JUUL 1.7% ENDS
Tobacco flavored JUUL 1.7% ENDS (10 puffs)
Intervention: Tobacco flavored JUUL 1.7% ENDS (Other)
Tobacco flavored JUUL 5% ENDS
Tobacco flavored JUUL 5% ENDS (10 puffs)
Intervention: Tobacco flavored JUUL 5% ENDS (Other)
Mint flavored JUUL 1.7% ENDS
Mint flavored JUUL 1.7% ENDS (10 puffs);
Intervention: Mint flavored JUUL 1.7% ENDS (Other)
Fruit Medley flavored JUUL 1.7% ENDS
Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)
Intervention: Fruit Medley flavored JUUL 1.7% ENDS (Other)
Fruit Medley flavored JUUL 5% ENDS
Fruit Medley flavored JUUL 5% ENDS (10 puffs)
Intervention: Fruit Medley flavored JUUL 5% ENDS (Other)
Crème brulee flavored JUUL 1.7% ENDS
Crème brulee flavored JUUL 1.7% ENDS (10 puffs)
Intervention: Crème brulee flavored JUUL 1.7% ENDS (Other)
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs
Intervention: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs (Other)
JUUL 5% ENDS 10 puffs vs. ad lib puffs
Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs
Intervention: JUUL 5% ENDS 10 puffs vs. ad lib puffs (Other)
Outcomes
Primary Outcomes
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
Time Frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine
Time Frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)
Time Frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour
Time Frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Secondary Outcomes
- Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.(38 Days)
- To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.(38 Days)