In this section, we introduce data from three clinical studies we have performed on our In-direct heating tobacco system platform 1 (IT1).

IT1: Biomarkers of Exposure study

We compared the uptake of HPHCs into the body when using IT1 and cigarettes.

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Methods

Sixty smokers were divided into three groups (20 smokers in each group): (a) switching to IT1, (b) continuing to smoke cigarettes (Control), and (c) smoking cessation (benchmark for exposure reduction). The levels of 16 selected biomarkers of exposure (BoE) were investigated over five days.

study-design

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RESULTS

  • All the BoE measured were significantly reduced in group (a) who switched to IT1 as compared to the group (b) who continued to smoke cigarettes.
  • The magnitude of the reduction in BoE, except nicotine, observed in group (a) who switched to IT1 was similar to that observed in group (c) who quit smoking.

Reference: Yuki D., Takeshige Y., Nakaya K., Futamura Y.: Assessment of the exposure to harmful and potentially harmful constituents in healthy Japanese smokers using a novel tobacco vapor product compared with conventional cigarettes and smoking abstinence. Regul Toxicol Pharmacol, 96, 127-134 (2018)

Study ID: UMIN000025777

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IT1: Biomarkers of potential harm study

We assessed the levels of biomarkers of potential harm (BoPHs) in cigarette smokers, IT1 users and never users.

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Methods

We measured seven BoPHs in 259 daily IT1 users, 100 cigarette smokers and 100 never-users (adults who had never used any tobacco or nicotine-containing products), and then compared the measured values among the groups.

study-design

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Results

  • The measured values of all BoPHs in IT1 users were significantly different from those of cigarette smokers.
  • The measured values in IT1 users were observed to be close to those of never-smokers.

Reference: Sakaguchi C., Nagata, Y., Kikuchi, A., Takeshige, Y., Minami, N.: Differences in Levels of Biomarkers of Potential Harm Among Users of a Heat-Not-Burn Tobacco Product, Cigarette Smokers, and Never-Smokers in Japan: A Post-Marketing Observational Study, Nicotine Tob Res, 23, 1143-1152 (2021).

Study ID: UMIN000036304

IT1: Nicotine Pharmacokinetics study

We assessed the pharmacokinetics of nicotine in human subjects who used IT1 and cigarettes.

 

Methods

The levels of nicotine in the blood were measured in 24 smokers who used IT1 and cigarettes, respectively, under certain conditions*.
* Three-minute use (ten puffs at 20-second intervals)

 

Results

  • Peak nicotine levels (Cmax) and overall nicotine levels (AUC) in blood (plasma) were lower following use of IT1 compared with cigarette smoking.
  • In addition, no significant difference was observed between IT1 use and smoking in terms of the time to peak blood nicotine levels (Tmax).

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study-design

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