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

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT04891406
• Lead Sponsor: Imperial Brands PLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Results First Submitted: 2022-07-06
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Results First Posted: 2023-10-13
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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	Maximum plasma concentration of nicotine (Cmax)
Nicotine 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	Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)

Secondary Outcome Measures

Name	Time	Method
Nicotine Extraction	20 minutes	Extraction fraction (%) of nicotine in used product pouches after 20 minutes of use.

Trial Locations

Locations (1)

CTC Clinical Trial Consultants AB (CTC); 🇸🇪 Uppsala, Sweden