Clinical trial NCT04891406: A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products
Official title: A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products (Traditional Snus, Conventional Cigarette and Three Oral Tobacco-free Nicotine Delivery Products)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Imperial Brands PLC
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.

During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
* Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and \>5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP
* Positive for HIV, hepatitis B or C
* After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

  * Systolic blood pressure \<90 or \>140 mmHg, or
  * Diastolic blood pressure \<50 or \>90 mmHg, or
  * Pulse \<40 or \>90 bpm
* Alcohol or drug abuse
* Use, or history of use of anabolic steroids
* Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
* Excessive caffeine consumption (daily intake of \>5 cups)
* Female subjects who are pregnant or breastfeeding

Primary outcomes:
measure: Nicotine Cmax
timeFrame: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
measure: Nicotine AUCt
timeFrame: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Secondary outcomes:
measure: Nicotine Extraction
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB (CTC)
Study officials:
References:
citation: Chapman F, McDermott S, Rudd K, Taverner V, Stevenson M, Chaudhary N, Reichmann K, Thompson J, Nahde T, O'Connell G. A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes. Psychopharmacology (Berl). 2022 Sep;239(9):2931-2943. doi: 10.1007/s00213-022-06178-6. Epub 2022 Jun 23.