Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
ConditionSmoking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorPhilip Morris Products S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
As per the Investigator's judgment, the participant cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
Participant has a health condition which requires medication or any other clinically relevant finding based on available assessments from the Screening period (e.g., safety panel, pulmonary function test, vital signs, physical examination, ECG, and medical history), as determined by the Principal Investigator or designee.
Participant experienced within 30 days prior to screening/admission a body temperature >37.9°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.).
Trial design
Treatments tested in this trial
- THS1 (TP18 variant 1)
- THS2 (TP18 variant 2)
- THS3 (TP18 variant 3)
- THS4 (TP18 variant 4)
- THS5 (THS 3.0 reference device)
- CIG (Cigarette)
Treatment groups
108 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov