Once a product platform shows promising data in toxicological assessment, we conduct clinical studies to understand what happens when adult smokers switch to the product.
Understanding whether the product is likely to be acceptable to adult smokers
The first type of clinical study we conduct is a pharmacokinetic and pharmacodynamic study. We are interested to understand how the smoker’s body absorbs the nicotine that is delivered by an RRP and how long it is present in the body following use of the product – this is called pharmacokinetics. For adult smokers to accept an RRP as an alternative to cigarettes, it is important that the nicotine uptake is similar to that which they experience following use of a cigarette. We also want to understand how a subject feels after having used an RRP, in particular their urge to smoke again – this is called pharmacodynamics. Both the pharmacokinetics and pharmacodynamics of an RRP should be similar to what happens when smokers use cigarettes in order to ensure that current adult smokers find it easier to switch to RRPs and not revert back to cigarette use.
Understanding whether adult smokers are exposed to fewer harmful chemicals
The platform development phase tells us whether the levels and numbers of harmful chemicals in the RRP vapors are significantly lower than in cigarette smoke in laboratory studies. In clinical assessment, we assess whether adult smokers are actually exposed to less of these chemicals when they use the RRP. Exposure to these chemicals can be determined by biomarkers of exposure. Biomarkers of exposure are the breakdown products of the chemicals that can be measured either in the blood or urine of adult smokers. These studies known as reduced exposure studies and they are always conducted in adult smokers. During the study, the smokers are split into three groups: one group that continues to use cigarettes, one group that stops smoking for the duration of the study and one group that switches to the RRP. By doing this we can compare the levels of biomarkers between the three groups to understand whether switching to the RRP reduces the levels of biomarkers compared to on-going smoking and whether the levels achieved come close to the levels seen in smoking cessation.
Determining whether switching to an RRP produces changes in markers of smoking-related disease
The final type of clinical study we conduct is known as an exposure response study. If the reduced exposure studies show a reduction in exposure to the harmful chemicals, exposure response studies are used to determine if this reduction in exposure to harmful chemicals translates into changes in short term health effects known to be associated with smoking-related diseases. An example of this is the measurement blood cholesterol. It is well known that there is good cholesterol and bad cholesterol and that smoking causes a shift in the balance towards more bad cholesterol. In our studies, for example, we assess if switching to RRPs readdresses this balance. In total we measure a total of 12 parameters which give an indication of health risk when adult smokers take part in these studies.