An interventional study of Conventional cigarettes (CC) and THS 2.1 in Smoking, sponsored by Philip Morris Products S.A.. Completed at 1 site in Poland. Open to participants aged 23 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by Philip Morris Products S.A. · Not applicable, Interventional, and Other
The goal of this exploratory study is to evaluate the effect of a candidate modified risk tobacco product (MRTP), THS 2.1, on selected biomarkers of exposure to harmful and potentially harmful smoke constituents (HPHCs), compared to conventional cigarettes (CC). The subjective effects (urge to smoke and withdrawal symptoms) which are related to the use of this product will be explored. Initial information on safety and on some biological effects when using THS 2.1 will be collected. Human Smoking Topography (HST) will be explored.
This study intends to evaluate the levels of selected biomarkers of exposure to selected HPHC and of cytochrome P450 1A2 (CYP1A2) enzymatic activity, as compared to smokers continuing smoking CC ad libitum, after 5 days of ad libitum use.
Additional parameters will be explored, such as: cytochrome P450 2A6 (CYP2A6) enzymatic activity, nicotine pharmacokinetics, product evaluation and safety, marker of platelet function, and HST.
After screening, subjects will be admitted to the clinic for 9 days, including the Day of Admission, 2 days of baseline during which all subjects will continue to smoke their usual CC for a 5-day exposure after randomization. After leaving the clinic on the Day of Discharge, the subjects will be followed up for safety over a period of 7 days. All subjects will receive smoking cessation advice at screening, at Day of Admission and at Day of Discharge.
This clinical study will be conducted in compliance with International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH Good Clinical Practice), the Declaration of Helsinki as amended in 2008, and the applicable regulatory requirements.
Philip Morris Products S.A. is the lead sponsor of 46 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Main Exclusion Criteria:
Smokers are continuing to smoke exclusively their usual own brand of CC, for 5 days, ad libitum, under highly controlled conditions
Other: Conventional cigarettes (CC)
Smokers are switching to the exclusive and ad-libitum use of THS 2.1 for 5 days, under highly controlled conditions
Other: THS 2.1
Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1
Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1
Evaluation of carboxyhemoglobin (COHb) levels in blood, and evaluation of excretion of 3-hydroxypropyl mercapturic acid (3-HPMA), monohydroxybutenyl mercapturic acid (MHBMA), and S-phenyl mercapturic acid (S-PMA) in 24-hour urine on switching to THS 2.1
Biomarkers of exposure to carbon monoxide (CO), acrolein, 1,3-butadiene, and benzene
Time frame: 5 days
Selected secondary biomarkers of exposure to HPHCs
Evaluation of the levels of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL),1-hydroxypyrene , total N-nitrosonornicotine (NNN), 4-aminobiphenyl (4-ABP), 2- aminonaphthalene (2-NA), o-toluidine, nicotine equivalents and 2-cyanoethylmercapturic acid, biomarkers of exposure to the HPHCs 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanone, NNN, 4-ABP, 2-NA, o-toluidine, nicotine and acrylonitrile, respectively, as excreted in urine.
Time frame: 5 days
CYP1A2 activity and CYP2A6 activity
Evaluation of the CYP1A2 activity, as measured by the plasma caffeine molar metabolic ratio (paraxanthine / caffeine) and in CYP2A6 activity, as measured by nicotine molar metabolic ratio (3-hydroxy-cotinine / cotinine) in plasma and in urine
Time frame: 5 days
Plasma nicotine
Time course of nicotine plasma concentrations and derived pharmacokinetic parameters
Time frame: 5 days
11-dehydro-thromboxane B2 (11-DTX-B2)
To describe the 11-DTX-B2 levels in urine as a marker of platelet function
Time frame: 5 days
Product use and smoking topography
Monitoring of daily product use and human smoking topography
Time frame: Up to 5 days
Safety monitoring
Monitoring of adverse events, based on clinical and laboratory evaluation
Time frame: 8 days + 7 days follow-up
Cough Visual Analog Scale (Cough VAS)
Visual Analog Scale on cough
Time frame: 7 days
Modified Cigarette Evaluation Questionnaire (MCEQ)
MCEQ measuring subjective effects of smoking
Time frame: 5 days
Questionnaire on Smoking Urges (brief version) (QSU-brief)
QSU-brief measuring subjective effects of smoking
Time frame: 5 days
Minnesota Withdrawal Scale-Revised (MNSWS-R)
MNWS-R questionnaire measuring subjective effects of smoking
Time frame: 5 days
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Philip Morris Products S.A.