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Trial registered on ANZCTR


Registration number
ACTRN12618000849291
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
21/05/2018
Date last updated
21/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the JUUL 5% Nicotine Salt Based ENDS Product, When Used by Current Smokers.
Scientific title
A Five-sequence, Partially Randomized Crossover Pilot Study Comparing Nicotine Pharmacokinetics of a Traditional Tobacco Cigarette and JUUL 5% Nicotine Salt Based ENDS Product, in Healthy Adult Male Smokers
Secondary ID [1] 293949 0
CH-1701 / 1
Universal Trial Number (UTN)
NA
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 306448 0
Condition category
Condition code
Mental Health 306026 306026 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive a total of five “doses” of nicotine (1-3 mg), delivered in a randomized order. There will be a washout of at least 120 minutes between the first inhalation of each product. The use of the term “dose” in this protocol does not mean to imply that the products are intended as therapeutics or smoking cessation products - dose will be variable depending on inhalation techniques - hence concentration and puffs given for strength of ''dose''.. Treatments to be administered in the current study are
Tobacco flavoured JUUL 5% nicotine-salt based ENDS product (vapour cigarette device dose equivalent to one cigarette), consumed in ad libitum inhalations for a period of 4.5 minutes. and
Tobacco flavoured JUUL 5% nicotine-salt based ENDS product (vapour cigarette device dose equivalent to one cigarette), consumed in 10 inhalations on the same day, once only..

All treatments will be delivered once on the same day at the study site with 120 mins between treatments.

Other 3 doses are outlined in the comparator control section.
Intervention code [1] 300214 0
Lifestyle
Comparator / control treatment
Traditional tobacco cigarette (Pall Mall), consumed in ad libitum inhalations (this dose will be received twice) and traditional tobacco cigarette (Paul Mall), consumed in 10 inhalations on the same day, once only at the study site.
All treatments will be delivered once on the same day with 120 mins between treatments.
Control group
Active

Outcomes
Primary outcome [1] 304666 0
To compare nicotine pharmacokinetics (PK) obtained with:
-Traditional tobacco cigarette versus JUUL 5% nicotine salt based ENDS product (tobacco flavour) via blood samples collected 5 minutes prior to initiation of the first inhalation (-5 min) and 0.0, 1.5, 3.0, 5.0, 7, 10, 12, 15, 30 and 60 minutes after initiation of the first inhalation of each product.
The primary variables are the pharmacokinetic parameters Tmax, Cmax, Cmax-baseline and AUC1hour of nicotine
Timepoint [1] 304666 0
collected 5 minutes prior to initiation of the first inhalation (-5 min) and 0.0, 1.5, 3.0, 5.0, 7, 10, 12, 15, 30 and 60 minutes after initiation of the first inhalation of each product.
Primary outcome [2] 305370 0
To compare nicotine pharmacokinetics (PK) obtained with:
Cigarette / e-cigarette consumption under different delivery conditions (10 puffs versus ad libitum puffs)
he primary variables are the pharmacokinetic parameters Tmax, Cmax, Cmax-baseline and AUC1hour of nicotine
Timepoint [2] 305370 0
collected 5 minutes prior to initiation of the first inhalation (-5 min) and 0.0, 1.5, 3.0, 5.0, 7, 10, 12, 15, 30 and 60 minutes after initiation of the first inhalation of each product.
Secondary outcome [1] 342723 0
Safety will be assessed initially by screening physical examination and laboratory tests (basic biochem and Haematology screen). On Day 1, vital signs and adverse events will be monitored
Timepoint [1] 342723 0
Screening and Day 1

Eligibility
Key inclusion criteria
1. Males aged 18 to 45 years of age inclusive.
2. BMI between 18 to 32 kg / m2 inclusive.
3. Healthy on the basis of medical history and screening assessments, in the opinion of the Investigator.
4. Current smokers of at least 7 cigarettes per week on average.
5. Able to participate, and willing to give written informed consent and to comply with the study restrictions.
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
No
Key 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 results for urine drugs of abuse test or alcohol breath test at screening.
6. Regular use of e-cigarettes only, with no regular use of cigarettes (dual cigarette / e-cigarette users are permitted).
7. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
8. Exposure to an investigational drug in a clinical trial within 1 month prior to dosing.
9. Blood or plasma donation of > 500 mL within 1 month prior to dosing.
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.

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



Intervention assignment
Crossover
Other design features
This is an open label, partially randomized, 5-sequence crossover pilot study.
The study will enrol 6 evaluable healthy adult male smokers.
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
The primary variables are the pharmacokinetic parameters Tmax, Cmax, Cmax-baseline and AUC1hour of nicotine. Plasma concentrations and the computed plasma PK parameters will be listed for each nicotine treatment. Individual and mean concentration versus time will be plotted on semi-logarithmic scales.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9553 0
New Zealand
State/province [1] 9553 0
Christchurch

Funding & Sponsors
Funding source category [1] 298578 0
Commercial sector/Industry
Name [1] 298578 0
JUUL Labs
Address [1] 298578 0
660 Alabama Street,
Second Floor, San Francisco,
CA 94110
Country [1] 298578 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
JUUL Labs
Address
660 Alabama Street,
Second Floor, San Francisco,
CA 94110
Country
United States of America
Secondary sponsor category [1] 297732 0
None
Name [1] 297732 0
Address [1] 297732 0
Country [1] 297732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299544 0
Northern A Health & Disability Ethics Comiittee
Ethics committee address [1] 299544 0
Ministry of Health
Ethics Department, Freyberg Building
Reception- Ground Floor, 20 Aitken Street
Wellington 6145
Ethics committee country [1] 299544 0
New Zealand
Date submitted for ethics approval [1] 299544 0
Approval date [1] 299544 0
17/02/2017
Ethics approval number [1] 299544 0

Summary
Brief summary
Subjects will be screened for participation up to 28 days before dosing. Subjects will be trained in the use of study product following completion of screening procedures. Subjects meeting all entry criteria at screening will be admitted to the clinic on Day 1. Eligible subjects will remain at the clinic until all study-related assessments are completed.
Subjects will receive a total of five “doses” of nicotine, delivered in a randomized order. There will be a washout of at least 120 minutes between the first inhalation of each product. A product and its associated assessments will be referred to in this protocol as a “dosing period”. The use of the term “dose” in this protocol does not mean to imply that the products are intended as therapeutics or smoking cessation products.
A. Tobacco flavour JUUL 5% nicotine salt based ENDS product, consumed in ad libitum puffs
B. Tobacco flavour JUUL 5% nicotine salt based ENDS product, consumed in 10 puffs
C. Traditional tobacco cigarette (Pall Mall), consumed in ad libitum puffs
D. Traditional tobacco cigarette (Pall Mall), consumed in 10 puffs
Treatments will be administered open label.
Each subject will then receive a second “dose” of treatment A.
For Products B and D, the subject will be asked to inhale 10 times, with 30 seconds between inhalations, using the assigned product. With each inhalation procedure, subjects will be instructed to breathe in gently (“puff”) for 3 seconds, remove the JUUL from their mouth, and then inhale prior to exhaling.
For Products A and C, the subject will be asked to consume the product using ad libitum puffs. The time to consumption of the product should be similar to that of products B and D for all subjects
PK samples will be collected up to 5 minutes prior to initiation of the first inhalation (- 5 min); 0.0, 1.5, 3.0, 5.0, 7, 10, 12, 15 and 30 minutes after initiation of the first inhalation in each dosing period; and 60 minutes after initiation of the first inhalation in dosing periods 1 – 4.
A product evaluation questionnaire will be completed after collection of the 30-minute PK sample for Treatments A and C, in dosing periods 1 – 4 only.
Subjects will be discharged after completion of safety and PK evaluations for the final dosing period.
The end of the trial is defined as the date of the last visit of the last subject undergoing the trial.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80794 0
Dr Chris Wynne
Address 80794 0
Christchurch Clinical Studies Trust
31 Tuam Street
Christchurch 8011
New Zealand
Country 80794 0
New Zealand
Phone 80794 0
+64 3 372 9477
Fax 80794 0
Email 80794 0
chris@ccst.co.nz
Contact person for public queries
Name 80795 0
Ms Jo Saunders
Address 80795 0
Christchurch Clinical Studies Trust
31 Tuam Street
Christchurch 8011
New Zealand
Country 80795 0
New Zealand
Phone 80795 0
+64 3 372 9477
Fax 80795 0
Email 80795 0
jo@ccst.co.nz
Contact person for scientific queries
Name 80796 0
Dr Chris Wynne
Address 80796 0
Christchurch Clinical Studies Trust
31 Tuam Street
Christchurch 8011
New Zealand
Country 80796 0
New Zealand
Phone 80796 0
+64 3 372 9477
Fax 80796 0
Email 80796 0
chris@ccst.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary