Alternative consumer products to current daily users of any tobacco and/or non-medicinal electronic nicotine delivery products Not Applicable
Conditions
Interventions
Screening (Days -28 to Day -1):
Screening assessments will be performed from Days -28 to Day -1, to ensure the eligibility of participants. Subjects will be selected for participation
the continued eligibility of each subject will be assessed by an Investigator.
On Day 1, after a minimum of 2-hour nicotine abstinence, eligible subjects will be asked to use the stud
Sponsors
JT International SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subject who are current daily users of any tobacco and / or non-medicinal electronic nicotine delivery products., between 19 and 65 years of age, inclusive. Age verification will be performed by checking valid forms of government-issued identification (e.g., passport, driving licence or validate UK card) during Screening. 2. Female subject of childbearing potential willing to use 2 effective methods of contraception, i.e., established method of contraception + condom, if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from the first dose until 1 month after the last dose of IP. 3. Female subject of non-childbearing potential. For the purposes of this study, this is defined as the subject being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy). 4. Female subject with a negative pregnancy test at Screening Visit and before the first dose administration of the IP on Day 1. 5. Female subject of post-menopausal status confirmed by demonstrating at Screening Visit that the serum level of the follicle-stimulating hormone (FSH) falls within the respective pathology reference range. In the event a subject's menopausal status has been clearly established (for example, the subject indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the subject’s eligibility to be included in the study will be at the Investigator’s discretion following consultation with the Sponsor. 6. Male subject willing to use 2 effective methods of contraception, i.e., established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 visit until completion of the Follow Up Phone Call. 7. Subject with a BMI of = 18.0 or =32.0 kg/m2 8. Prior to study start, subjects must be a self-reported current daily user of any tobacco and/or non-medicinal electronic nicotine delivery product (with at least 12 months of consistent use), who are not intending to make a quit attempt, change / alter their tobacco or nicotine usage during the study and up to completion of the post-study telephone follow-up call that can tolerate an e-liquid concentration of up to 18 mg/mL prior to the Screening Visit. This should include conventional cigarette smokers, e-cigarette users, roll-your-own cigarette smokers or dual users (of either conventional cigarette and/or roll-your-own cigarette smokers and e-cigarette users). 9. No clinically significant abnormal laboratory test results (in the opinion of the investigator) for serum biochemistry and haematology within 28 days before receiving the first dose administration of the IP. 10. Subject with a negative urinary DOA screen (including alcohol) test results, determined within 28 days before the first dose administration of the IP unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the subject has been presc
Exclusion criteria
Exclusion criteria: 1. Subject who is a menthol cigarette smoker or menthol e-cigarette user 2. Subject who is a snuff or snus tobacco user 3. Subject who has any clinically relevant abnormal findings on the physical examination, medical history, lung function tests, 12-lead ECG, or clinical laboratory evaluations, unless deemed not clinically significant by the investigator or their appropriately qualified designee 4. Subject who has, or who has had a relevant history of any clinically significant: neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, or haematological conditions and/or other significant medical conditions including, without limitation, those pertaining to COVID-19 that, in the opinion of the Investigator or their appropriately qualified designee, would jeopardise the safety of the subject, safety of anyone involved in the study or impact on the validity of the study results 5. Subject who has used prescription or over-the-counter bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to Screening visit 6. Subject who has received any medications or substances (other than tobacco) which are known to be strong inducers or inhibitors of cytochrome P450 (CYP) and CY2A6 enzymes within 14 days (or 5 half-lives (whichever is longer) prior to Screening 7. Subject who has a clinically significant acute illness (e.g., respiratory tract infection) requiring treatment within 4 weeks prior to first dose 8. Subject who, prior to enrolment, is planning to quit/reduce their tobacco/nicotine usage during the study and up to completion of the post-study telephone follow-up call. All subjects will be informed that they are free to quit nicotine use and withdraw from the study at any time 9. Subject who has had any treatment with smoking cessation medications (e.g., Bupropion, Champix or any nicotine replacement therapies (NRTs)) within 8 weeks of the planned first nicotine dosing occasion 10. Subject who is unwilling to trial the study product during their Screening and/or Day 1 Visit 11. Female subject who is pregnant or breastfeeding or intending to become pregnant during the course of the study. This will be confirmed with a pregnancy test performed at Screening and before the first product use. and on Admission. Any female subject who becomes pregnant during this study will be withdrawn 12. Subject is a current or former employee of the tobacco and vaping industry or is a first-degree relative (parent, sibling, child) 13. Subject with a known allergy to the components of the Investigational Products 14. Subject who is unable or unwilling to participate in the Day 1 visit 15. Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the Day 1 visit (washout period between studies is defined as the period of time elapsed between receiving the last dose of the previous study and receiving the first dose of the next study) 16. Subject who, in the opinion of the Investigator, is unsuitable for participation in the study 17. A clinically significant history of drug or alcohol ab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration-time profiles of propylene glycol (PG) in exhaled breath following the use of a Logic Compact E-cigarette and Tobacco flavour pod under two fixed-vaping regimens. This will be measured through exhalation into a PTR-TOF-MS instrument at the following timepoints: Product Use Periods 1 & 2: 5 minutes prior to product use, each exhalation during product use (Period 1 only) , 5 mins, 10 mins, 20 mins, 30 mins, 40 mins, 50 mins, 60 mins, 90 mins, 120 mins post-product use* Product Use Periods 3 & 4: 5 minutes prior to product use, each exhalation during product use, 5 mins, 10 mins post-product use* *At each timepoint listed above, participants are required to breathe into the machine once every 20 seconds for a 2-minute period. For periods 3 and 4, participants are required to breathe into the machine every 20 seconds for a period of 5 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Concentration-time profiles for the following volatile organic compounds (VOCs): vegetable glycerol (VG), nicotine, phenyl carbinol, pyrazines (2, 3, 5-trimethylpyrazine), vanillin (vanillin PG acetals), theobromine, ethanol, methyl cyclopentenolone, propenyl guaethol measured using PTR-TOF-MS at the timepoints listed below 2. The pharmacokinetic parameters derived from concentration-time profiles of PG, VG and nicotine in exhaled breath following the use of a Logic Compact E-cigarette and Tobacco flavour pod under two fixed-vaping regimens using Phoenix WinNonLin 3. The theoretical consumed amounts of PG, VG and nicotine using PTR-TOF-MS at the timepoints listed below 4. Potential adverse events and concomitant medication whilst using and/or following use of the Logic Compact E-cigarette and Tobacco flavour pod with a nicotine concentration of 12 mg/ml recorded from the time of informed consent to post-study follow-up phone call. Product Use Periods 1 & 2: 5 minutes prior to product use, each exhalation during product use (Period 1 only) , 5 mins, 10 mins, 20 mins, 30 mins, 40 mins, 50 mins, 60 mins, 90 mins, 120 mins post-product use* Product Use Periods 3 & 4: 5 minutes prior to product use, each exhalation during product use, 5 mins, 10 mins post-product use* *At each timepoint listed above, participants are required to breathe into the machine once every 20 seconds for a 2-minute period. For periods 3 and 4, participants are required to breathe into the machine every 20 seconds for a period of 5 minutes. | — |
Countries
United Kingdom, Wales
Contacts
Public ContactLesley Giles
Outcome results
None listed