The purpose of this study is to develop a fit-for-purpose biochemical verification tool that can be used to detect concomitant use of a few (less than 5) conventional cigarettes.
This study will be performed in two parts. The first part, Part A, is a dose titration study in healthy smokers with incremental cigarette consumption performed in confinement. The second part, Part B, is an observational study on healthy non-smokers in an ambulatory setting PART A (smokers only) A screening visit will be conducted within 4 weeks prior to admission to the investigational site. The 8-day confinement period consists of the admission day (Day1), 1 day ad-libitum smoking (Day0), 3 days of smoking abstinence (Day1-3), 2-day exposure period smoking 2 and 4 cigarettes (Day4-5), and the day of discharge (Day6) followed by a 7-day safety follow-up period. Urine collection will be performed for each subject from Day0 to Day5 in 4 intervals. PART B (non-smokers) Screening visit will be conducted within 4 weeks prior to the ambulatory Visit 1 (collection of 24-hour urine and spot urine) to the investigational site. The minimum interval between the screening and Visit 1 is of 7 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
88
Smoking abstinence, smoking 2 and 4 cigarettes
Simbec Research Ltd
Merthyr Tydfil, South Wales, United Kingdom
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour urine of smokers smoking 2 or 4 conventional cigarettes
To demonstrate that CEMA, used as a urinary biomarker, can identify subjects who have smoked 4 or less conventional cigarettes
Time frame: After smoking 2 or 4 conventional cigarettes, within 24 hours
Levels of CEMA in 24-hour urine, carboxyhaemoglobin (COHb) in blood and carbon monoxide in exhaled breath of smokers smoking 2 or 4 conventional cigarettes
To evaluate the ability of CEMA to detect conventional cigarette use in comparison to COHb and exhaled carbon monoxide
Time frame: After smoking 2 or 4 conventional cigarettes, within 24 hours
Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour and spot urine of non-smokers
To evaluate the correlation between the levels of CEMA in 24-hour urine and in spot urine in non-smokers
Time frame: 24 hours
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