Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variant
This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to smokers who continue smoking CIG after 5 days of confinement period, followed by 2 days of p
| Condition(s) | Smoking |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to smokers who continue smoking CIG after 5 days of confinement period, followed by 2 days of pharmacokinetic (PK) period of single use of THS/TP18 and CIG, and followed by an ambulatory period. |
| Who can participate | Inclusion Criteria: * Participant has signed the ICF and understands the information provided in it. * Participant is male or female and between 21 and 65 years old (inclusive). * Participant has been a smoker for at least 2 years prior to the screening visit and is willing to switch to THS and TP18. * Participant has smoked on average ≥10 commercially available CIGs/day over the last 30 days. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL). * Participant does not plan to quit smoking within the next three months. * Participant is available for the entire study period and willing to comply with the study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco-containing products, and willing to adhere to a sta |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Philip Morris Products S.A. |
| Locations | Belfast, United Kingdom |
| Start date | 2026-02-19 |
| NCT ID | NCT07443631 |
| Official listing | https://clinicaltrials.gov/study/NCT07443631 |