None listed
Conditions
Brief summary
This is a Phase 1, single centre, open-label study to investigate the PK profile, safety and tolerability and pharmacodynamics (PD) of single ascending doses of nicotine administered in single and multiple inhalations via a Miist Nicotine Inhaler in healthy male smokers. Study participants will receive 3 inhaled doses of the investigational nicotine replacement therapy (NRT) product. The doses will be administered via the novel Miist Nicotine Inhaler in increasing order of strength of nicotine, starting from 0.08 mg and increasing to 0.16 mg then 1.15 mg with a 120 minute (+15 minutes) washout period between each dose level.
Interventions
Study participants will receive 3 inhaled doses of the investigational nicotine replacement therapy (NRT) product as a self-administered dose via the Miist Nicotine Inhaler.
Study participants will receive training on how to use the Miist Nicotine Inhaler from the site research team. Training with a sham device will take place at the time of screening, at clinic check in and prior to each dose. The site research team will supervise each dose.
Study participants will be instructed to fully exh
Study participants will receive 3 inhaled doses of the investigational nicotine replacement therapy (NRT) product as a self-administered dose via the Miist Nicotine Inhaler. Study participants will receive training on how to use the Miist Nicotine Inhaler from the site research team. Training with a sham device will take place at the time of screening, at clinic check in and prior to each dose. The site research team will supervise each dose. Study participants will be instructed to fully exhale. A flashing blue light will be visible when the device is ready. They will place the mouthpiece in their mouth and inhale firmly and deeply such that the steady blue light remains on, increasing their inhalation effort if the blue light stops or slowing their inhalation if a red light flashes. At the end of the dose delivery, the steady blue light will go off and the motor in the device will stop. The participant is to hold their breath for 5 seconds prior to exhaling and ending the dose. The doses will be administered in increasing order of strength of nicotine, starting from 0.08 mg and increasing to 0.16 mg then 1.15 mg with a 120 minute (+15 minutes) washout period between each dose level.
Sponsors
Miist Therapeutics South Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Male between 18 and 55 years of age, inclusive. 2. Cigarette smoker who smokes more than 10 cigarettes (tobacco cigarettes alone or in combination with e-cigarettes) a day and who has smoked for 1 year. 3. Able to abstain from smoking and use of other nicotine containing products (e.g., gum, patches or any other Nicotine Replacement Treatment product) for 12 hours prior to study dosing and for the duration of confinement in the Clinical Research Unit. 4. Have a Fagerström Test for Nicotine Dependence (FTND) score of at least 4. 5. Body weight above 50 kg and body mass index (BMI) in the range 19 to 35 kg per m2 (inclusive). 6. Willing and able to have an arterial line inserted and maintained for blood sampling for PK. 7. Healthy as determined by a licensed and experienced physician, based on a medical evaluation including medical history, physical examination, safety laboratory tests and cardiac monitoring. A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The Investigator may discuss with the local MM and Sponsor representative as required. 8. Estimated glomerular filtration rate (eGFR) must be above 60 mL per min per 1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula). 9. Normal standard 12-lead ECG parameters after at least 5 minutes resting in supine position 10. Normal vital signs after at least 5 minutes resting semi-supine: 11. Must agree to abstain from heterosexual intercourse for at least 12 hours following discharge from the Clinical Research Unit. 12. Provides written informed consent and is willing and able to undergo all study procedures and participate in the scheduled follow up teleconference call per protocol.
Exclusion criteria
1. Known or suspected history of allergy or sensitivity to nicotine or any other component of the inhaler. 2. A history of Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening 3. History of confirmed chronic and/or serious pulmonary disease, including asthma, or chronic obstructive pulmonary disease, a history of myocardial infarction or cerebrovascular accident, other clinically significant cardiac, liver or renal conditions, or any comorbidity that could place them at risk or interfere with the interpretation of the study data. 4. Participant with a diagnosed bleeding disorder or significant bruising or bleeding difficulties with blood draws or is unable to provide a blood sample without undue trauma or distress or has poor peripheral arterial and/or venous access. 5. Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or IP administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator or Sponsor, would make the participant inappropriate for entry into this trial. 6. Participant requiring any inhaled or anti-coagulant medications. 7. Inability to use the Miist Nicotine Inhaler correctly following training. 8. A positive pre-study drug or alcohol screen. 9. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units for males. 10. Participation in a clinical trial within 30 days before dosing; use of any experimental therapy within 30 days or 5 half-lives prior to dosing, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to dosing, whichever is greater. 11. Participant unable to provide written informed consent or participant under guardianship. 12. Unwilling or unable to follow protocol requirements.
Outcome results
None listed