Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Condition(s) studied
Investigational drug(s) / intervention(s)
THS1 (TP18 variant 1): TP18 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): TP18 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): TP18 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): TP18 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): THS 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): Current cigarette smokers will use their usual brand of commercially available CIG.
Study 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.
Eligibility
Primary outcome measure(s)
- 3-hydroxypropyl mercapturic acid (3-HPMA) in Urine (confinement period) — Measured from Day -1 to Day 5.
Concentrations of 3-HPMA measured in 24-hour urine and expressed as concentration adjusted for creatinine. - 2-cyanoethyl mercapturic acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA) in Urine (confinement period) — Measured from Day -1 to Day 5.
Concentrations of 2-CyEMA measured in 24-hour urine and expressed as concentration adjusted for creatinine. - Monohydroxybutenyl mercapturic acid (MHBMA) in Urine (confinement period) — Measured from Day -1 to Day 5.
Concentrations of MHBMA measured in 24-hour urine and expressed as concentration adjusted for creatinine. - Total N-nitrosonornicotine (total NNN) in Urine (confinement period) — Measured from Day -1 to Day 5.
Concentrations of total NNN measured in 24-hour urine and expressed as concentration adjusted for creatinine. - Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in Urine (confinement period) — Measured from Day -1 to Day 5.
Concentrations of total NNAL measured in 24-hour urine and expressed as concentration adjusted for creatinine. - Carboxyhemoglobin (COHb) in Blood (confinement period) — Measured from Day -1 to Day 5.
Carboxyhemoglobin (COHb) is assayed from whole blood and expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Celerion | Belfast | United Kingdom |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07443631 on ClinicalTrials.gov ↗ ← All trials in the UK