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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03593239




Registration number
NCT03593239
Ethics application status
Date submitted
1/06/2018
Date registered
20/07/2018

Titles & IDs
Public title
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
Scientific 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
Secondary ID [1] 0 0
PROT-00008 / v2.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nicotine Dependence 0 0
Nicotine Dependence, Cigarettes 0 0
Tobacco Use 0 0
Tobacco Smoking 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Tobacco flavored JUUL 1.7% ENDS
Other interventions - Tobacco flavored JUUL 5% ENDS
Other interventions - Mint flavored JUUL 1.7% ENDS
Other interventions - Mint flavored JUUL 5% ENDS
Other interventions - Fruit Medley flavored JUUL 1.7% ENDS
Other interventions - Fruit Medley flavored JUUL 5% ENDS
Other interventions - Crème brulee flavored JUUL 1.7% ENDS
Other interventions - Crème brulee flavored JUUL 5% ENDS
Other interventions - JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
Other interventions - JUUL 5% ENDS 10 puffs vs. ad lib puffs

Experimental: Tobacco flavored JUUL 1.7% ENDS - Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Experimental: Tobacco flavored JUUL 5% ENDS - Tobacco flavored JUUL 5% ENDS (10 puffs)

Experimental: Mint flavored JUUL 1.7% ENDS - Mint flavored JUUL 1.7% ENDS (10 puffs);

Experimental: Mint flavored JUUL 5% ENDS - Mint flavored JUUL 5% ENDS (10 puffs)

Experimental: Fruit Medley flavored JUUL 1.7% ENDS - Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)

Experimental: Fruit Medley flavored JUUL 5% ENDS - Fruit Medley flavored JUUL 5% ENDS (10 puffs)

Experimental: Crème brulee flavored JUUL 1.7% ENDS - Crème brulee flavored JUUL 1.7% ENDS (10 puffs)

Experimental: Crème brulee flavored JUUL 5% ENDS - Crème brulee flavored JUUL 5% ENDS (10 puffs)

Experimental: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs - Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs

Experimental: JUUL 5% ENDS 10 puffs vs. ad lib puffs - Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs


Other interventions: Tobacco flavored JUUL 1.7% ENDS
Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Other interventions: Tobacco flavored JUUL 5% ENDS
Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)

Other interventions: Mint flavored JUUL 1.7% ENDS
Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)

Other interventions: Mint flavored JUUL 5% ENDS
Treatment with Mint flavored JUUL 5% ENDS(10 puffs)

Other interventions: Fruit Medley flavored JUUL 1.7% ENDS
Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)

Other interventions: Fruit Medley flavored JUUL 5% ENDS
Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)

Other interventions: Crème brulee flavored JUUL 1.7% ENDS
Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)

Other interventions: Crème brulee flavored JUUL 5% ENDS
Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)

Other interventions: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs

Other interventions: JUUL 5% ENDS 10 puffs vs. ad lib puffs
Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)
Timepoint [1] 0 0
38 Days
Primary outcome [2] 0 0
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
Timepoint [2] 0 0
38 Days
Primary outcome [3] 0 0
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour
Timepoint [3] 0 0
38 Days
Primary outcome [4] 0 0
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine
Timepoint [4] 0 0
38 Days
Secondary outcome [1] 0 0
Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
Timepoint [1] 0 0
38 Days
Secondary outcome [2] 0 0
To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.
Timepoint [2] 0 0
38 Days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2018
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Juul Labs, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Wynne, MD
Address 0 0
Christchurch Clinical Studies Trust Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03593239