Switching adult smokers from cigarettes to prototype heated tobacco devices (TP18/THS) to lower exposure

A Randomized, Controlled, Open-label, 6 Parallel Arms Study to Assess Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) of Cigarette (CIG) Smoke in Adult Smokers Switching to Tobacco Heating Systems (THS/TP18) With Different Device Variants as Compared to Continuing CIG Smoking

This trial will test whether adult smokers who switch to different prototype heated tobacco device variants have lower exposure to certain harmful tobacco chemicals than those who keep smoking cigarettes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Philip Morris Products S.A. (Industry-sponsored)
• Locations: 1 site (Belfast)
• Trial ID: NCT07443631 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled, open-label study with six parallel arms comparing five TP18/THS device variants versus continued cigarette smoking. Participants complete a 5-day confinement period using only their assigned product, followed by a 2-day pharmacokinetic single-use crossover (except the cigarette arm), and then an ambulatory period with ad libitum product use. The main measurements are changes in selected biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs). Device variants include THS1–THS4 (TP18 prototypes) and THS5 (THS 3.0 reference device).

Who should consider this trial

Good fit: Adults aged 21–65 who have smoked ≥10 commercial cigarettes per day for at least two years, are not planning to quit within three months, and can comply with confinement, product-use assignments, and study visits.

Not a fit: Non-smokers, light or occasional smokers, people planning to quit soon, or those unwilling/unable to use the assigned heated devices or comply with study procedures are unlikely to benefit.

Why it matters

Potential benefit: If switching lowers biomarker levels, participants could have reduced exposure to selected harmful tobacco constituents compared with continuing to smoke cigarettes.

How similar studies have performed: Previous industry and some academic reports have shown reductions in biomarkers of exposure after switching to heated tobacco products, but evidence of long-term health benefit is still lacking.

Eligibility criteria

Inclusion Criteria:

* 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).
* Participant does not plan to quit smoking within the next three months.
* Participant is available for the entire study period and willing to comply with the study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco-containing products, and willing to adhere to a standardized diet (during confinement period and during overnight stays on Day 30 and Day 60).

Exclusion Criteria:

* 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.).
* According to the Investigator's judgment, the participant has medical conditions that require or will require medical intervention (e.g., initiation of treatment, surgery, hospitalization) during the study period, which may interfere with study participation and/or study results.
* Participant uses medication that aids in smoking cessation.
* Participant experiences difficulty with venipuncture and/or poor venous access.
* Participant has a hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening visit.
* Participant has a positive nitrite urinary test at screening or on admission day (Day -2)
* Participant has donated blood or received whole blood or blood products within the past 3 months.
* BMI \< 18.5 kg/m2 or ≥ 32.0 kg/m2.
* Positive serology test for HIV 1/2, HBV, or HCVa.
* Participant has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
* The participant has a positive urine drug test.
* Participant or one of their family members is a current or former employee of the tobacco industry, manufacturing or distributing e-cigarettes or other nicotine/tobacco-containing products.
* A participant or a family member is an employee of the investigational site or of any other parties involved in the study.
* Participant has participated in another clinical study within 30 days or within a period equivalent to five half-lives of the investigational product from that study, whichever is longer. .
* Participant has been previously screened or enrolled in this study (unless they are alternate subjects).
* Female participant is pregnant (does not have negative pregnancy tests at screening and/or at admission) or is breastfeeding.
* For women of childbearing potential only and males: participant does not agree to use an acceptable method of effective contraception.

Where this trial is running

Belfast

• Celerion — Belfast, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Christelle Haziza, PhD

Conditions Smoking; HPHC