Alternative consumer products for current daily users of any tobacco and/or non-medicinal electronic nicotine delivery products Not Applicable
Conditions
Interventions
Participants will be randomly allocated one of the product sequences (A-B / B-A, 10 subjects per sequence) according to a randomisation code produced by Simbec-Orion using the PROC PLAN procedure of S
Sponsors
Japan Tobacco (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged from 19 to 65 years at Screening Visit 2. Participant lives in the UK 3. Participant is able to read, understand and sign a Patient Information Sheet (PIS) and Informed Consent Form (ICF) and complete questionnaires written in English 4. Participants with a negative COVID-19 test on Day -1 5. Participant must be a tobacco or nicotine containing product user for 12 months and have been using a commercially available, nicotine-containing closed tank/cartridge e-cigarette (in which the e-liquid contains nicotine up to 20 mg/ml), daily for at least 3 months prior to the Screening Visit 6. Participant has positive urine cotinine tests (> 200 ng/mL) at Screening Visit and Check-in 7. Participant is a healthy participant, as judged by the Principal Investigator, based on all available assessments at Screening Visit and Check-in (e.g., safety laboratory measures, spirometry [forced expiratory volume in 1 second {FEV1} s/forced vital capacity {FVC} >0.7 at post-bronchodilator basal spirometry, post-bronchodilator FEV1 >80% predicted value, and post-bronchodilator FVC >0.8], vital signs, physical examination, 12-lead ECG, and medical history). 8. Participant is willing to comply with all investigation procedures 9. Female participant of childbearing potential who must be willing to use two effective forms of contraception from the time of signing the ICF until 1 month following the last product use session on Day 2 or be surgically sterile for at least 3 months prior to the Screening Visit. 10. Male participant (and partner of childbearing potential) willing to use two effective forms of contraception (see Section 10.5.1), if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the time of signing the ICF until completion of the post-study follow up telephone call. 11. Female participant of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a participant’s menopausal status has been clearly established (for example, the participant 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 participant’s eligibility to be included in the study will be at the Investigator’s discretion following consultation with the Sponsor. 12. Participant who, prior to enrolment, is not planning to quit/reduce their cigarette/nicotine usage in the next 4 weeks. All participants will be informed that they are free to quit nicotine use and withdraw from the study at any time.
Exclusion criteria
Exclusion criteria: 1. As per Principal Investigator judgment, the participant cannot participate in the study for any reason (e.g., medical, psychiatric, poor peripheral venous access, and/or social reason) 2. Participant is legally incompetent, physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners or participant who is involuntarily incarcerated) 3. Participant has a medical condition that requires smoking cessation, or clinically relevant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease, or any other medical condition [including but not limited to clinically relevant abnormal laboratory parameters]) in the judgment of the Principal Investigator. 4. As per Principal Investigator judgment, the participant has medical conditions which required or in the course of the study would have required, a medical intervention (e.g., the start of treatment, surgery, hospitalization) which could have interfered with the study participation and/or study results 5. Participant has a body mass index (BMI) <18.5 kg/m² or BMI =32.0 kg/m² at the Screening Visit 6. Participants who have an acute illness (e.g., upper respiratory tract infection, viral infection, etc) requiring treatment within 4 weeks prior to Screening or on admission 7. Participant has received any treatment with smoking cessation medications (e.g., Bupropion, Chantix or any form of nicotine replacement therapy) within 4 weeks prior to Check-in 8. Participant has received medication (prescription or over-the-counter [OTC] – not including COVID-19 vaccination which is allowed during the study duration) within 14 days or within 5 half-lives of the drug prior to Check-in that had an impact on CYP2A6 activity. 9. Participant has a positive alcohol test and/or participant has a history of alcohol abuse that could interfere with participant’s participation in study 10. Participant has a positive urine drug test 11. Participant has used e-cigarette in which e-liquid contains cannabis within 3 months prior to Check-in 12. Participant has positive serology test for human immunodeficiency virus (HIV) 1/2, hepatitis B, or hepatitis C 13. Participant violates local rules of blood donation in terms of acceptable amounts of blood drawn in a certain period of time, due to blood sampling in this study 14. Participant is a current or former employee of the tobacco or vaping industry or is a first-degree relative (parent, sibling, child) 15. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first product use. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study). 16. Participant has previously participated in the same study at a different time (i.e., each participant can be included in the study population only once) 17. Female participant of childbearing potential who is pregnant o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nicotine pharmacokinetic (PK) parameters following single and multiple ad libitum use of two variants of the commercially available e-cigarette Logic Compact pods. The parameters to be calculated are as follows: 1. Maximum observed plasma nicotine concentration (Cmax, single) following a single ad libitum use 2. Area under the plasma nicotine concentration versus time curve from time zero to 240 min post-start of a single ad libitum use (AUC0-240) 3. Time of maximum observed plasma concentration (tmax, single) following a single ad libitum use 4. Maximum plasma nicotine concentration (Cmax, multi) following a multiple ad libitum use Assessment Days 1 & 2: Blood samples will be taken at the following timepoints: 5 min, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 30 min, 60 min, 120 min, 240 min & at 6 h, 8 h, and 10 hours following the start of 5-minute single ad libitum use session on each day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective effects measured using Subjective Effects Questionnaires at 10 min and 10 hours following the start of 5 minute single ad lib use session on each day 2. Heart rate and blood pressure measured using DINAMAP* Compact Vital Signs Monitor (Model TS) 10 minutes prior to the start of single ad libitum use, and at 10 min, 30 min, 60 min, 120 min, 240 minutes and 10 hours following the start of 5 minute single ad lib use session on each day 3. Theoretical consumed nicotine measured using product weight prior to and following completion of each single ad lib use and multiple ad lib use session on each day 4. Adverse events (AEs) collected from informed consent through to the post-study telephone call 5. Intent to use the product again measured using the visual analogue scale (VAS) after single and multiple ad libitum use 6. Satisfaction, psychological rewards, aversion, enjoyment of respiratory tract sensations and craving reduction measured using subscales of the modified Product Evaluation Scale (mPES) after single and multiple ad libitum use Physiological endpoint: 1. Blood pressure (BP) and heart rate (HR) measured using DINAMAP* Compact Vital Signs Monitor (Model TS) at baseline and up to 240 minutes following the start of single ad libitum use Safety endpoints: 1. Overall physical health measured using physical examination at screening, Day -1 & Day 3 (prior to discharge) 2. Vital signs (except physiological endpoints) measured using DINAMAP* Compact Vital Signs Monitor (Model TS) at screening, Day -1 & Day 3 (prior to discharge) 3. ECG parameters measured using 12-lead electrocardiogram (ECG) at screening, Day -1 & Day 3 (prior to discharge) 4. Laboratory safety parameters measured using clinical laboratory evaluations at screening, Day -1 & Day 3 (prior to discha | — |
Countries
United Kingdom, Wales
Contacts
Public ContactMyriam;Lesley Mouhib;Giles
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Outcome results
None listed