SmokingNCT07443631
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
A study testing THS1 (TP18 variant 1), THS2 (TP18 variant 2) and THS3 (TP18 variant 3) in people with Smoking, run by Philip Morris Products S.A. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- THS1 (TP18 variant 1), THS2 (TP18 variant 2) and THS3 (TP18 variant 3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2026to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the detailed description
This randomized, controlled, open-label study comprises six parallel arms and is designed to evaluate reductions in biomarkers of exposure (BoE) to selected HPHCs in adult smokers switching toTP18 (a prototype heated tobacco device with four variants: THS1, THS2, THS3, THS4) or THS5 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.
During the 5-day confinement period, participants will be randomized to use only their assigned product and will operate their assigned devices (THS1, THS2, THS3, THS4, or THS5) with their corresponding sticks or continue smoking CIG ad libitum (6 arms in total).
In the subsequent 2-day PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. Participants randomized to the CIG arm at Baseline will not participate in this period.
During the ambulatory period, participants randomized to one of the TP18 versions at Baseline will be free to choose and use any TP18 variant at any time, ad libitum. Participants randomized at Baseline to TP18 will continue using THS ad libitum. Participants randomized to the CIG arm will only be smoking cigarettes, ad libitum.
- Conditions
- Smoking
- Being tested
- THS1 (TP18 variant 1), THS2 (TP18 variant 2), THS3 (TP18 variant 3), THS4 (TP18 variant 4), THS5 (THS 3.0 reference device)
- Keywords
- HPHC
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THS1 (TP18 variant 1)Other
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)Other
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)Other
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)Other
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)Other
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)Other
Current cigarette smokers will use their usual brand of commercially available CIG.
| Study group | Role | What they receive |
|---|---|---|
| THS1 | Other | During the confinement period, participants will use only their assigned product THS 1 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. Receives: Other: THS1 (TP18 variant 1) |
| THS2 | Other | During the confinement period, participants will use only their assigned product THS 2 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. Receives: Other: THS2 (TP18 variant 2) |
| THS3 | Other | During the confinement period, participants will use only their assigned product THS 3 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. Receives: Other: THS3 (TP18 variant 3) |
| THS4 | Other | During the confinement period, participants will use only their assigned product THS 4 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. Receives: Other: THS4 (TP18 variant 4) |
| THS5 | Other | During the confinement period, participants will use only their assigned product THS 5 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they will be continue to use THS5 ad libitum. Receives: Other: THS5 (THS 3.0 reference device) |
| CIG | Other | During the confinement period, participants will use only their usual brand of commercially available CIG ad libitum.
This arm will not participate in the PK period and will move directly to the ambulatory period. During the ambulatory period, participants will smoke only cigarettes, ad libitum. Receives: Other: CIG (Cigarette) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured from Day -1 to Day 5.
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.
Measured: Measured from Day -1 to Day 5.
Monohydroxybutenyl mercapturic acid (MHBMA) in Urine (confinement period)
Concentrations of MHBMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured: Measured from Day -1 to Day 5.
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.
Measured: Measured from Day -1 to Day 5.
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in Urine (confinement period)
Concentrations of total NNAL measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured: Measured from Day -1 to Day 5.
Carboxyhemoglobin (COHb) in Blood (confinement period)
Carboxyhemoglobin (COHb) is assayed from whole blood and expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Measured: Measured from Day -1 to Day 5.
Secondary outcomes (6)
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.
Measured: Measured from Day -1 to Day 5.
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.
Measured: Measured from Day -1 to Day 5.
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.
Measured: Measured from Day -1 to Day 5.
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.
Measured: Measured from Day -1 to Day 5.
4-aminobiphenyl (4-ABP) in Urine (confinement period)
Concentrations of 4-ABP measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured: Measured from Day -1 to Day 5.
2-aminonaphtalene (2-NA) in Urine (confinement period)
Concentrations of 2-NA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured: Measured from Day -1 to Day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start19 Feb 2026
- Primary completion29 Jul 2026
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christelle Haziza, PhD, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443631
- Sponsor's protocol ID
- P1-REX_PK-22
- Status last verified
- Nov 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07443631
- Acronym / sponsor ID
- P1-REX_PK-22
- Conditions
- Smoking
- Keywords
- HPHC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, controlled, open-label study comprises six parallel arms and is designed to evaluate reductions in biomarkers of exposure (BoE) to selected HPHCs in adult smokers switching toTP18 (a prototype heated tobacco device with four variants: THS1, THS2, THS3, THS4) or THS5 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.
During the 5-day confinement period, participants will be randomized to use only their assigned product and will operate their assigned devices (THS1, THS2, THS3, THS4, or THS5) with their corresponding sticks or continue smoking CIG ad libitum (6 arms in total).
In the subsequent 2-day PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. Participants randomized to the CIG arm at Baseline will not participate in this period.
During the ambulatory period, participants randomized to one of the TP18 versions at Baseline will be free to choose and use any TP18 variant at any time, ad libitum. Participants randomized at Baseline to TP18 will continue using THS ad libitum. Participants randomized to the CIG arm will only be smoking cigarettes, ad libitum.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| THS1 | Other | Other: THS1 (TP18 variant 1)During the confinement period, participants will use only their assigned product THS 1 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. |
| THS2 | Other | Other: THS2 (TP18 variant 2)During the confinement period, participants will use only their assigned product THS 2 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. |
| THS3 | Other | Other: THS3 (TP18 variant 3)During the confinement period, participants will use only their assigned product THS 3 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. |
| THS4 | Other | Other: THS4 (TP18 variant 4)During the confinement period, participants will use only their assigned product THS 4 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum. |
| THS5 | Other | Other: THS5 (THS 3.0 reference device)During the confinement period, participants will use only their assigned product THS 5 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they will be continue to use THS5 ad libitum. |
| CIG | Other | Other: CIG (Cigarette)During the confinement period, participants will use only their usual brand of commercially available CIG ad libitum. This arm will not participate in the PK period and will move directly to the ambulatory period. During the ambulatory period, participants will smoke only cigarettes, ad libitum. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | THS1 |
| 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. | Other | THS2 |
| 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. | Other | THS3 |
| 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. | Other | THS4 |
| 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. | Other | THS5 |
| CIG (Cigarette)Current cigarette smokers will use their usual brand of commercially available CIG. | Other | CIG |
Primary outcome
3-hydroxypropyl mercapturic acid (3-HPMA) in Urine (confinement period)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
6 secondary outcomes
S-phenylmercapturic acid (S-PMA) in Urine (confinement period)
Time frame: Measured from Day -1 to Day 5.
2-hydroxyethylmercapturic acid (2-HEMA) in Urine (confinement period)
Time frame: Measured from Day -1 to Day 5.
3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) in Urine (confinement period)
Time frame: Measured from Day -1 to Day 5.
Total 3-hydroxybenzo(a)pyrene (3-OH-B[a]P) in Urine (confinement period)
Time frame: Measured from Day -1 to Day 5.
4-aminobiphenyl (4-ABP) in Urine (confinement period)
Time frame: Measured from Day -1 to Day 5.
2-aminonaphtalene (2-NA) in Urine (confinement period)
Time frame: Measured from Day -1 to Day 5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Haziza, PhD study chair
Philip Morris Products S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THS1 (TP18 variant 1), THS2 (TP18 variant 2) and THS3 (TP18 variant 3) in people with Smoking, run by Philip Morris Products S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-hydroxypropyl mercapturic acid (3-HPMA) in Urine (confinement period) (time frame: Measured from Day -1 to Day 5.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.