Actively Recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Led by Philip Morris Products S.A. · Updated on 2026-05-01
108
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and understands study information
- Male or female aged between 21 and 65 years inclusive
- Smoked cigarettes for at least 2 years before screening
- Smoked on average 10 or more cigarettes per day over the last 30 days
- Verified smoking status with urinary cotinine level of 200 ng/mL or higher
- No plans to quit smoking within the next three months
- Available for entire study period and willing to follow study procedures including product use and abstinence requirements
- Willing to adhere to a standardized diet during confinement and overnight stays on Day 30 and Day 60
You will not qualify if you...
- Unable to participate for non-medical reasons (e.g., psychological, social) as judged by Investigator
- Legally incompetent or physically/mentally unable to give consent
- Health conditions requiring medication or clinical intervention affecting study participation
- Fever over 37.9°C or acute illness within 30 days before screening
- Medical conditions needing intervention during study that may interfere with results
- Use of smoking cessation medication
- Difficulty with venipuncture or poor venous access
- Hemoglobin below 11.0 g/dL (females) or below 12.0 g/dL (males) at screening
- Positive nitrite urinary test at screening or admission
- Blood donation or transfusion within past 3 months
- Body mass index less than 18.5 or 32.0 or higher
- Positive tests for HIV 1/2, HBV, or HCV
- Positive alcohol breath test or history of alcohol disorder affecting participation
- Positive urine drug test
- Participant or family member employed in tobacco industry or investigational site
- Participation in another clinical study within 30 days or five half-lives of prior investigational product
- Previously screened or enrolled in this study unless alternate subject
- Pregnant or breastfeeding females without negative pregnancy tests
- Females of childbearing potential and males not agreeing to use effective contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Celerion
Belfast, United Kingdom, BT9 6AD
Actively Recruiting
Research Team
C
Christelle Haziza, PhD
CONTACT
S
Sandrine Pouly, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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