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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
THS1 (TP18 variant 1)
Other interventionTP18 prototype variant "1" (THS1) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
THS2 (TP18 variant 2)
Other interventionTP18 prototype variant "2" (THS2) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
THS3 (TP18 variant 3)
Other interventionTP18 prototype variant "3" (THS3) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
THS4 (TP18 variant 4)
Other interventionTP18 prototype variant "4" (THS4) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
THS5 (THS 3.0 reference device)
Other interventionTHS 3.0 device (reference) and the corresponding tobacco sticks will be provided by the Sponsor. There are two variants of the sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants may choose either variant or both.
CIG (Cigarette)
Other interventionCurrent cigarette smokers will use their usual brand of commercially available CIG.
Treatment groups
108 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: THS1Other 1 intervention
Group B: THS2Other 1 intervention
Group C: THS3Other 1 intervention
Group D: THS4Other 1 intervention
Group E: THS5Other 1 intervention
Group F: CIGOther 1 intervention
Trial outcomes
Primary outcomes
1
3-hydroxypropyl mercapturic acid (3-HPMA) in Urine (confinement period)
Concentrations of 3-HPMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.2
2-cyanoethyl mercapturic acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA) in Urine (confinement period)
Concentrations of 2-CyEMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.3
Monohydroxybutenyl mercapturic acid (MHBMA) in Urine (confinement period)
Concentrations of MHBMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.4
Total N-nitrosonornicotine (total NNN) in Urine (confinement period)
Concentrations of total NNN measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.Secondary outcomes
1
S-phenylmercapturic acid (S-PMA) in Urine (confinement period)
Concentrations of S-PMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.2
2-hydroxyethylmercapturic acid (2-HEMA) in Urine (confinement period)
Concentrations of 2-HEMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.3
3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) in Urine (confinement period)
Concentrations of 3-HMPMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.4
Total 3-hydroxybenzo(a)pyrene (3-OH-B[a]P) in Urine (confinement period)
Concentrations of 3-OH-B\[a\]P measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Time frame
Measured from Day -1 to Day 5.Other outcomes
1
Plasma nicotine concentrations [C0h] to [C6h] (pharmacokinetic period)
To measure the background-corrected plasma nicotine concentrations (C0h) to (C12h)
Time frame
Measured from Day 6 to Day 7.2
Maximum plasma nicotine concentration [Cmax] (pharmacokinetic period)
To measure the background-corrected maximum plasma nicotine concentration \[Cmax\]
Time frame
Measured from Day 6 to Day 7.3
Area under the plasma nicotine concentration-time curve (pharmacokinetic period)
To measure the area under the background-corrected plasma nicotine concentration-time curve (AUC) from the start of product use (T0) to the timepoint of last quantifiable concentration \[AUC0-last\] and extrapolated to infinity \[AUC0-infinity\]
Time frame
Measured from Day 6 to Day 7.4
Maximum concentration [Tmax] (pharmacokinetic period)
To measure the time to the background-corrected maximum concentration \[Tmax\]
Time frame
Measured from Day 6 to Day 7.Sponsors and contacts
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Source ClinicalTrials.gov