The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
169
THS 2.2 ad libitum for 5 days in confinement
SA for 5 days in confinement
Subject's own preferred brand of CC ad libitum for 5 days in confinement
BioVirtus Research Site Sp. z o.o.
Kajetany, Poland
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics.
Time frame: 5 days
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 5 days
Concentration of S-phenylmercapturic Acid (S-PMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 5 days
Levels of Carboxyhemoglobin (COHb)
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.
Time frame: 5 days
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