Actively Recruiting
A Randomized, Controlled, Open-label Study to Assess Exposure to Harmful Constituents in Adult Smokers Switching to Tobacco Heating System Variants Compared to Continuing Cigarette Smoking
Led by Philip Morris Products S.A. · Updated on 2026-05-01
108
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the exposure to selected harmful and potentially harmful constituents (HPHCs) in adult smokers who switch from cigarettes to various versions of a prototype heated tobacco device called TP18 or continue smoking cigarettes. This randomized, controlled, open-label study includes six parallel groups and aims to compare the biomarkers of exposure after switching to one of the TP18 device variants or continuing cigarette smoking. The study is sponsored by Philip Morris Products S.A. and focuses on adult smokers aged 21 to 65 years. Participants are randomly assigned to one of six groups: five groups use different TP18 device variants (THS1, THS2, THS3, THS4, or THS5) with corresponding tobacco sticks, and one group continues smoking their usual brand of cigarettes. The study includes a 5-day confinement period where participants use only their assigned product, followed by a 2-day pharmacokinetic period involving a four-way crossover for those in the TP18 groups. The cigarette group does not participate in this crossover. An ambulatory period follows, during which TP18 users can choose any device variant freely, while the cigarette group continues smoking only cigarettes. During the study, researchers will collect urine and blood samples to measure various biomarkers related to tobacco exposure, such as 3-HPMA, 2-CyEMA, MHBMA, total NNN, total NNAL, and COHb. Additional secondary biomarkers will also be assessed. Participants will be monitored for adherence to product use, dietary restrictions during confinement, and safety through clinical assessments. The total study duration includes confinement, pharmacokinetic evaluation, and ambulatory follow-up to observe changes in exposure over time.
CONDITIONS
Brief 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...
- Participant has signed the informed consent and understands the study information.
- Male or female between 21 and 65 years old inclusive.
- Smoker for at least 2 years prior to screening and willing to switch to heated tobacco devices.
- Smoked an average of 10 or more commercially available cigarettes per day over the last 30 days.
- Smoking status confirmed by urinary cotinine test (≥200 ng/mL).
- No plans to quit smoking within the next 3 months.
- Available for the entire study period and willing to follow study procedures, including product use and dietary restrictions during confinement and overnight stays.
You will not qualify if you...
- Unable to participate for non-medical reasons (psychological, social).
- Legally incompetent or unable to give consent.
- Health conditions requiring medication or clinically relevant findings from screening assessments.
- Recent fever over 37.9°C or acute illness within 30 days before screening.
- Medical conditions needing treatment, surgery, or hospitalization during the study that may affect participation.
- Use of smoking cessation medications.
- Difficulty with blood draws or poor venous access.
- Low hemoglobin levels at screening (<11.0 g/dL females, <12.0 g/dL males).
- Positive nitrite urinary test at screening or admission.
- Blood donation or transfusion in past 3 months.
- Body mass index less than 18.5 or greater than or equal to 32.0 kg/m2.
- Positive tests for HIV, HBV, or HCV.
- Positive alcohol breath test or history of alcohol disorder.
- Positive urine drug test.
- Participant or family member is current or former tobacco industry employee.
- Participant or family member works at investigational site or related parties.
- Participation in another clinical study within 30 days or equivalent to five half-lives of investigational product.
- Previously screened or enrolled in this study unless alternate subject.
- Pregnant or breastfeeding females.
- Women of childbearing potential and males not agreeing to effective contraception use during the study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants use only their assigned product (one of the THS/TP18 variants or their usual cigarettes) ad libitum during a 5-day stay under controlled conditions.
Daily visits during confinement
Duration - 2 days
Participants complete a 2-day four-way single-product crossover using the THS/TP18 variants and cigarettes according to randomized product sequences. Participants assigned to the cigarette arm do not participate in this period.
Daily visits during PK period
Duration - Duration not specified
Participants use their assigned products freely in an outpatient setting. Those initially assigned to THS variants may choose any variant at any time ad libitum. Those initially assigned to cigarettes continue smoking their usual brand ad libitum.
Visits as scheduled during ambulatory period
Trial Site Locations
Total: 1 location
1
Celerion
Belfast, United Kingdom, BT9 6AD
Actively Recruiting
Research Team
C
Christelle Haziza, PhD
S
Sandrine Pouly, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here