We conduct clinical studies of RRP* to assess the potential of our RRP* to reduce the risks associated with smoking under human use conditions. We carry out the clinical studies in accordance with the ethical principles for human research, the guidance for Good Clinical Practice (GCP), and local requirements, as applicable.
Why do we need clinical studies?
To understand the effects RRP* product use has on adult smokers, we don’t just rely on laboratory studies such as aerosol chemistry and toxicology, we also conduct studies with real people. In other words, we need to conduct clinical studies.
Such data not only helps us gain insight into the real word impact of using RRP* under human use conditions, but, in certain circumstances, is requested by regulatory authorities, for example when reviewing marketing claims suggesting that a product poses a lower risk of disease or exposure to harmful constituents.
Key clinical studies for RRP*:
- Biomarkers of Exposure study
- Biomarkers of Potential Harm study
- Nicotine pharmacokinetics
We introduce the results of our clinical studies here:
What is a Biomarker of Exposure study?
Biomarker of Exposure (BoE) studies assess the uptake of constituents, such as HPHCs, into the human body. This kind of clinical assessment is usually performed under human use conditions to better reflect what happens in the real world.
What is a Biomarker of Potential Harm study?
Biomarker of Potential Harm (BoPH) studies assess the biological impact of uptake of constituents into the body. Such data can be used to help evaluate the reduced-risk potential of RRP*.
Clinical outcomes, such as lung cancer, cardiovascular disease (CVD), and chronic obstructive pulmonary disease (COPD), may take decades to develop and thus are not always practical to assess in clinical studies. Therefore, it is important to assess early markers levels of diseases under actual product use conditions.
Specifically, BoPH studies assess whether levels of BoPH will improve after switching from cigarette smoking to RRP* use. Changes in certain BoPH levels are reported, through epidemiological and clinical evidence, to be predictive of smoking-related diseases.
Since clinical outcomes develop through multiple biological mechanisms, such as early biological effects, alterations in morphology, structure, or function, it is important to assess a set of biomarkers, rather than a single biomarker.
What is a nicotine Pharmacokinetics study?
Generally, pharmacokinetics (PK) studies evaluate the rate and extent to which an active component of the product is made available to the body and the way it is distributed in, metabolized by, and eliminated from the human body. Nicotine PK studies assess the pharmacokinetics of nicotine following the use of nicotine containing products, such as RRP* . The data are usually presented as several parameter values derived from the concentration of nicotine in the blood over time. Three key values are the highest concentration of nicotine reached (Cmax), the time to reach this concentration in the blood (Tmax) and the overall nicotine levels (AUC).
