A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
- Conditions
- Healthy Volunteers
- Interventions
- Other: Product AOther: Product BOther: Product COther: Product D
- Registration Number
- NCT05452278
- Lead Sponsor
- Imperial Brands PLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 27
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Product sequence ABCD Product B Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product sequence BCDA Product B Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product sequence CDAB Product B Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product sequence CDAB Product A Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product sequence CDAB Product D Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product sequence ABCD Product A Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product sequence BCDA Product A Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product sequence CDAB Product C Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product sequence DABC Product C Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Product sequence DABC Product D Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Product sequence ABCD Product D Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product sequence BCDA Product C Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product sequence BCDA Product D Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product sequence DABC Product B Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Product sequence ABCD Product C Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product sequence DABC Product A Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4
- Primary Outcome Measures
Name Time Method Nicotine AUCt 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 The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint
Nicotine Cmax 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 Maximum observed plasma nicotine concentration
- Secondary Outcome Measures
Name Time Method Extracted dose of nicotine 20 minutes Extraction fraction (%) of nicotine in the pouch after the 20-minute use period.
Urge to use Emax 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 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).
Trial Locations
- Locations (1)
CTC Clinical Trial Consultants AB
🇸🇪Uppsala, Sweden