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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05452278
Other study ID # IB-OND-ZONEX-11
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 21, 2021
Est. completion date July 31, 2023

Study information

Verified date May 2023
Source Imperial Brands PLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. The study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (PK) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation. During the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. A final follow up end-of-study telephone call will be performed within a week of last product use.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 27
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 99 Years
Eligibility Inclusion Criteria: - BMI = 18.0 and = 30.0 kg/m2 - Clinically normal medical history - User of snus or nicotine pouches for =1 year, with a minimum weekly use of 2 or more snus or nicotine pouch cans and who is willing and considered able to use brands with nicotine content in the range of 14 to 20 mg nicotine/pouch 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. - Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV - Female subjects who are pregnant or breastfeeding - Presence or history of drug or alcohol abuse - Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages - Intend to change nicotine-use habit or make a quit attempt within the next 3 months from the screening visit.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Product A
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Product B
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Product C
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Product D
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes

Locations

Country Name City State
Sweden CTC Clinical Trial Consultants AB Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Imperial Brands PLC

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nicotine Cmax Maximum observed plasma nicotine concentration 5 minutes prior to product use and 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
Primary Nicotine AUCt The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint 5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
Secondary Extracted dose of nicotine Extraction fraction (%) of nicotine in the pouch after the 20-minute use period. 20 minutes
Secondary Urge to use Emax The subjects will self-assess their urge to use a nicotine pouch, pre-use and after use, by answering the question: "How strong is your urge to use a nicotine pouch right now?" on a 100 mm visual analogue scale (VAS), with the anchor points 0 mm (= not at all/no urge) and 100 mm (= extremely/extreme urge). Emax is the maximum change from baseline VAS score (VASpre-use - VASpost-use). 5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
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