A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products

Healthy Volunteers Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891406
• Other study ID #: IB-OND-PKZX-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: October 2023
• Source: Imperial Brands PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• A
Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes
• B
Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes
• C
Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes
• D
Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes
• E
Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

Locations

Country	Name	City	State
Sweden	CTC Clinical Trial Consultants AB (CTC)	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 plasma concentration of nicotine (Cmax)	Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Primary	Nicotine AUCt	Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)	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	Nicotine Extraction	Extraction fraction (%) of nicotine in used product pouches after 20 minutes of use.	20 minutes