ptake of nicotine following a single use of Heat Not Burn (HNB) 1.2 and a cigarette
- Conditions
- icotine uptakeRespiratoryNicotine uptake
- Registration Number
- ISRCTN88682435
- Lead Sponsor
- Japan Tobacco International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
1. Aged between 21 to 50 years of age
2. Good general health
3. Smoker for at least 12 months prior to check-in and currently smokes an average of 10 or more manufactured cigarettes per day (no restriction on brand-style, king size [~83 – 85 mm] and 100s [~98 – 100 mm] only)
4. Positive urine cotinine at screening (> 200 ng/mL) at screening
5. Female subjects must be non-pregnant and non-lactating
5. Pre-menopausal female subjects must be surgically sterile, use an investigator-approved method of birth control, or agree to be sexually abstinent from 14 days prior to check-in through the end of the study
1. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
2. Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at Screening or Check-in, in the opinion of the Investigator
3. Positive test for HIV, HBsAg, or HCV
4. An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Check-in
5. Fever (>38?C) at Screening or at Check-in
6. Systolic blood pressure <90 mmHg or >150 mmHg, diastolic blood pressure <40 mmHg or >95 mmHg, or pulse rate <40 bpm or >99 bpm at screening
7. BMI <18 kg/m2 or >35 kg/m2 at screening
8. Use of prescription anti-diabetic medication and/or insulin therapy within 12 months of day 1 product administration.
9. Use of medications known to interact with CYP2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, methoxsalen) within 3 months prior to day 1 product administration
10. Use of inhalers to treat any medical condition within 3 months prior to day 1 product administration and throughout the study
11. Positive urine screen for alcohol or drugs of abuse at screening or at check-in
12. History or presence of alcoholism or drug abuse within the past 2 years prior to screening
13. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 ml of wine or 360 mL of beer or 45 mL of 45% alcohol
14. Males who have donated blood within 12 weeks or females who have donated blood within 16 weeks prior to day 1 product administration.
15. Donation of bone marrow within the last 6 months prior to day 1 product administration
16. Participation in a previous clinical study for an investigational drug, biologic, medical device, or tobacco product within 90 days prior to day 1 product administration
17. Planning to quit smoking during the study period or postponing a quit attempt in order to participate in the study
18. Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Champix®) or buproprion (Zyban®) within 3 months prior to day 1 product administration and throughout the study
19. Known hypersensitivity to glycerol or propylene glycol
20. Subject or a first-degree relative is a current or former employee of the tobacco industry or a named party or class representative in litigation with the tobacco industry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ptake of nicotine from the HNB 2.1 product as measured using plasma nicotine concentrations obtained from blood samples taken at 2, 3 ,4, 5, 6, 7, 8, 10, 15, 20, 25, 30, 45, 60 and 90 minutes following use of the HNB 1.2 product.
- Secondary Outcome Measures
Name Time Method 1. Nicotine pharmacokinetic parameters (e.g. maximum nicotine concentration (Cmax) and time to Cmax (tmax)) measured using plasma nicotine concentrations obtained from blood samples taken at 2, 3 ,4, 5, 6, 7, 8, 10, 15, 20, 25, 30, 45, 60 and 90 minutes following use of the HNB 1.2 product<br>2. Volunteer mouth level exposure (MLE) to nicotine during use of the HNB 2.1 product, as measured by the difference in weight of HNB 2.1 product + its associated pod insert before and after product use<br>3. Volunteer mouth level exposure (MLE) to nicotine during use of the CC1 product, as measured by assessing the amount of nicotine present in the product filter after product use<br>4. Volunteer inhalation to non-inhalation ratios during use of the HNB 2.1 product as measured by vidual analogue scare (VAS) questionnaire following use of the HNB 1.2 product