None listed
Conditions
Brief summary
The purpose of this study is to determine how safe and tolerable the Oxette (Registered Trademark) Nicotine Inhaler Pack is. This includes the device and how the nicotine is absorbed into your body and the levels of nicotine in your blood. The study is also looking to compare the Oxette (Registered Trademark) Nicotine Inhaler Pack against the Nicorette (Registered Trademark) Inhaler (this product is approved and readily available as a stop smoking aid), to see how the levels of nicotine in your blood from each product compare. This study consists of 4 different parts. PART A: A total of 18 participants. Will receive 2 different doses of nicotine on one single day. PART B: A total of 24 participants. Will receive 2 different dose levels of nicotine over three separate days. PART C: A total of 18 participants. Will all receive the same single dose level of nicotine every hour for 12 hours. Part D: A total of 24 participants. Will attend the clinical trial unit on two consecutive days and will be randomised to receive one complete refill of Oxette (Registered Trademark) Nicotine Inhaler device at the medium dose level of nicotine (0.056%w/w) on one day, and one treatment of Nicorette (Registered Trademark) Inhaler (10mg) on another day in random order.
Interventions
This study has been divided into four parts as described below. Part A: Single blind, randomised, multi dose-level study to evaluate the tolerability and pharmacokinetics of orally inhaled nicotine via the Oxette (Registered Trademark) Nicotine Inhaler pack at three doses of nicotine – low, medium and high. Two single different dose levels of nicotine will be inhaled using the device on a single study day, approximately 6 hrs apart. Part A High dose is 0.084% w/w Nicotine, Medium dose is 0.056%
This study has been divided into four parts as described below. Part A: Single blind, randomised, multi dose-level study to evaluate the tolerability and pharmacokinetics of orally inhaled nicotine via the Oxette (Registered Trademark) Nicotine Inhaler pack at three doses of nicotine – low, medium and high. Two single different dose levels of nicotine will be inhaled using the device on a single study day, approximately 6 hrs apart. Part A High dose is 0.084% w/w Nicotine, Medium dose is 0.056% w/w Nicotine, Low dose is 0.028% w/w Nicotine. Part B:Open label/single blind, randomised, 3-way crossover study to evaluate the pharmacokinetics of two dose levels of the Oxette (Registered Trademark) Nicotine Inhaler pack in comparison to the Nicorette (Registered Trademark) Inhaler. Two single different dose levels of nicotine will be inhaled using the Oxette device and one single dose level of nicotine will be inhaled using the Nicorette device over 3 days. One dose will be inhaled per day. There will be approximately 18hr break before moving to the next dose. The 2 dose levels will be determined based on the data obtained from Part A. Part C: Open label study to evaluate the tolerability and venous pharmacokinetics of repeat doses of orally inhaled nicotine via the Oxette (Registered Trademark) Nicotine Inhaler system at one dose level of nicotine. One dose level of nicotine will be inhaled using the Oxette device twelve times a day for one day. The dose level will be determined based on the data obtained from Parts A and B. Subjects will only participate in one of the three parts. The Oxette Inhaler pack and the Nicorette Inhaler differ in appearance and formulation of the nicotine. The devices used to inhale the nicotine also differ in appearance and functionality. Part D: Open label, randomised, 2-way crossover study to determine the venous pharmacokinetics of orally inhaled nicotine at the medium dose level (0.056%w/w) delivered via the Oxette (Registered Trademark) Nicotine Inhaler device in comparison to the Nicorette (Registered Trademark) Inhaler (10mg).
Sponsors
Kind Consumer Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Smoking male or female with a minimum age of at least 18 years and maximum age of 55 years. 2.Smoke greater than or equal to 10 manufactured cigarettes per day for the last year. 3. Smoke within 1 hour of waking. 4. Expired carbon monoxide greater than 10ppm at screening. 5. Body weight of at least 50 kg with a BMI range of 18.5 – 32. 6. Availability of participant for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, Informed Consent Form. 7. Normal findings in the physical examination, vital signs and a 12 lead ECG. 8. Women must be using one effective barrier method of contraception, be postmenopausal for at least 12 months prior to trial entry, or surgically sterile. Women of child-bearing potential must complete a serum pregnancy test prior to the first administration with a negative result.
Exclusion criteria
1. Known or suspected history of hypersensitivity to nicotine. 2. History of confirmed chronic and/or serious pulmonary disease, including asthma or COPD. 3. History of a heart attack or stroke. 4. Females who are pregnant or breastfeeding. 5. Participants with any co-morbidity, which in the opinion of the Principal Investigator, might place them at undue risk or which could interfere with the interpretation of study data. 6. Presence or history of clinically significant cardiac or renal conditions. 7. Participants taking prescription anticoagulant or anti-platelet medication. 8. Participating in a clinical trial with an investigational drug within 30 days preceding this trial. 9. Blood donation within 45 days preceding this trial. 10.Participants who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody or have a positive result to the test for Human Immunodeficiency Virus (HIV). 11. Participants who had a clinically significant positive drug screen result at either the screening visit or on admission. (A drug screen may only be repeated where methodological reasons are believed to have led to a false positive result).
Outcome results
None listed