None listed
Conditions
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.
Interventions
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 th
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.
Sponsors
JUUL Labs
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed