A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

Healthy Volunteers Clinical Trial

Official title:

A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05452278
• Other study ID #: IB-OND-ZONEX-11
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

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