CompletedNCT02641587Updated Feb 21, 2023Results posted

Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

An interventional study of CHTP 1.2 and CC in Smoking, sponsored by Philip Morris Products S.A.. Completed at 1 site in Poland. Open to participants aged 28 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Philip Morris Products S.A. (part of Philip Morris International) · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 121
Allocation: Randomized
Ages: 28 Years and older
Sex: All

Study summary

The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.

Conditions studied

Smoking

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Smoking 325

Keywords

Smoking
Cigarettes
Reduced exposure
Confinement
Ambulatory
Carbon Heated Tobacco Product

In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 121 is close to the median of 117 across 250 interventional studies indexed under Smoking.

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Lead sponsor

Philip Morris Products S.A. is the lead sponsor of 49 studies on the registry; none are open to participants now.

Browse Philip Morris Products S.A. studies →All Philip Morris International studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 28 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject is aged ≥ 28 years.
Subject is Caucasian.
Subject is healthy, as judged by the Investigator.
Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
Subject has smoked at least for the last 10 years.
Subject does not plan to quit smoking in the next 6 months.

Exclusion criteria

Exclusion Criteria:

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
Female subject is pregnant or breast feeding.
Female subject does not agree to use an acceptable method of effective contraception.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 121 participants (actual)

Study arms

Experimental
CHTP 1.2
Ad libitum use of the CHTP 1.2
Other: CHTP 1.2
Active comparator
CC
Ad libitum use of subject's own preferred non-menthol brand of CC
Other: CC

Interventions

OtherCHTP 1.2
Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.
OtherCC
Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

What researchers measure

Primary outcomes

Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Time frame: 5 days
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Time frame: 5 days
Concentration of S-phenylmercapturic Acid (S-PMA)
Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Time frame: 5 days
Levels of Carboxyhemoglobin (COHb)
% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Time frame: 5 days
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Concentrations measured at Day 90 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Time frame: 90 days

Results

Posted Mar 6, 2019

Participant flow

Confinement Period

Participant flow — Confinement Period
Milestone	CHTP 1.2	Cigarettes (CC)
Started	80	40
Completed	77	39
Not completed	3	1
Withdrew: Adverse event	1	0
Withdrew: Withdrawal by subject	2	1

Ambulatory Period

Participant flow — Ambulatory Period
Milestone	CHTP 1.2	Cigarettes (CC)
Started	77	39
Completed	76	39
Not completed	1	0
Withdrew: Withdrawal by subject	1	0

Outcome measures

PrimaryConcentrations of Monohydroxybutenylmercapturic Acid (MHBMA)

Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time frame:: 5 days
Reported as:: Geometric least squares mean · pg/mg creat

Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)
pg/mg creat	CHTP 1.2	Cigarettes (CC)
Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)	285.5 (258.0 to 315.8)	1904 (1641 to 2209)

Statistical analysis

CHTP 1.2 vs Cigarettes (CC) · Generalized linear model · p = <0.001 (The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.) · Ls mean reduction: 85.01 · 95% CI 82.06 to 87.47Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.

PrimaryConcentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

Time frame:: 5 days
Reported as:: Geometric least squares mean · ng/mg creat

Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
ng/mg creat	CHTP 1.2	Cigarettes (CC)
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	616.8 (565.6 to 672.8)	1031 (907.9 to 1172)

Statistical analysis

CHTP 1.2 vs Cigarettes (CC) · Generalized linear model · p = <0.001 (The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.) · Ls mean reduction: 40.20 · 95% CI 30.25 to 48.73Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.

PrimaryConcentration of S-phenylmercapturic Acid (S-PMA)

Time frame:: 5 days
Reported as:: Geometric least squares mean · pg/mg creat

Concentration of S-phenylmercapturic Acid (S-PMA)
pg/mg creat	CHTP 1.2	Cigarettes (CC)
Concentration of S-phenylmercapturic Acid (S-PMA)	386.6 (358.7 to 416.7)	2401 (2151 to 2681)

Statistical analysis

CHTP 1.2 vs Cigarettes (CC) · Generalized linear model · p = <0.001 (The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.) · Ls mean reduction: 83.90 · 95% CI 81.61 to 85.90Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.

PrimaryLevels of Carboxyhemoglobin (COHb)

% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time frame:: 5 days
Reported as:: Geometric least squares mean · % of saturation of hemoglobin

Levels of Carboxyhemoglobin (COHb)
% of saturation of hemoglobin	CHTP 1.2	Cigarettes (CC)
Levels of Carboxyhemoglobin (COHb)	2.01 (1.86 to 2.16)	4.53 (4.01 to 5.11)

Statistical analysis

CHTP 1.2 vs Cigarettes (CC) · Generalized linear model · p = <0.001 (The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.) · Ls mean reduction: 55.74 · 95% CI 49.03 to 61.56Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.

PrimaryConcentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)

Concentrations measured at Day 90 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time frame:: 90 days
Reported as:: Geometric least squares mean · pg/mg creat

Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
pg/mg creat	CHTP 1.2	Cigarettes (CC)
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)	37.26 (31.39 to 44.24)	180.6 (144.8 to 225.1)

Statistical analysis

CHTP 1.2 vs Cigarettes (CC) · Generalized linear model · p = <0.001 (The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.) · Ls mean reduction: 79.36 · 95% CI 72.73 to 84.39Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.

Adverse events

Collected over Adverse events were collected from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period, which covered a period of between 128 to 169 days for each subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Product Test	0/121 (0%)	0/121 (0%)	62/121 (51.2%)
CHTP 1.2 Confinement	0/80 (0%)	1/80 (1.3%)	37/80 (46.3%)
CC Confinement	0/40 (0%)	0/40 (0%)	12/40 (30%)
CHTP 1.2 Ambulatory	0/77 (0%)	1/77 (1.3%)	50/77 (64.9%)
CC Ambulatory	0/39 (0%)	1/39 (2.6%)	26/39 (66.7%)
CHTP 1.2 Safety FU	0/80 (0%)	0/80 (0%)	1/80 (1.3%)
CC Safety FU	0/40 (0%)	0/40 (0%)	1/40 (2.5%)
CHTP 1.2 Post-Randomization	0/80 (0%)	2/80 (2.5%)	64/80 (80%)
CC Post-Randomization	0/40 (0%)	1/40 (2.5%)	31/40 (77.5%)

Most frequent serious events

Most frequent serious events
Event	Product Test	CHTP 1.2 Confinement	CC Confinement	CHTP 1.2 Ambulatory	CC Ambulatory	CHTP 1.2 Safety FU	CC Safety FU	CHTP 1.2 Post-Randomization	CC Post-Randomization
Joint DislocationInjury, poisoning and procedural complications	0/121	0/80	0/40	0/77	1/39	0/80	0/40	0/80	1/40
AppendicitisInfections and infestations	0/121	0/80	0/40	1/77	0/39	0/80	0/40	1/80	0/40
Peritonsillar AbscessInfections and infestations	0/121	1/80	0/40	0/77	0/39	0/80	0/40	1/80	0/40

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Product Test	CHTP 1.2 Confinement	CC Confinement	CHTP 1.2 Ambulatory	CC Ambulatory	CHTP 1.2 Safety FU	CC Safety FU	CHTP 1.2 Post-Randomization	CC Post-Randomization
HeadacheNervous system disorders	42/121	9/80	4/40	14/77	8/39	0/80	0/40	20/80	11/40
HyperglycaemiaMetabolism and nutrition disorders	4/121	2/80	0/40	14/77	4/39	0/80	0/40	15/80	4/40
NasopharyngitisInfections and infestations	3/121	6/80	2/40	9/77	1/39	0/80	0/40	14/80	3/40
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders	1/121	2/80	2/40	3/77	2/39	0/80	0/40	5/80	4/40
General disordersGeneral disorders	6/121	6/80	3/40	1/77	1/39	0/80	0/40	7/80	4/40
CoughRespiratory, thoracic and mediastinal disorders	0/121	4/80	0/40	2/77	2/39	0/80	1/40	6/80	3/40
Alanine Aminotransferase IncreasedInvestigations	1/121	3/80	0/40	3/77	1/39	0/80	0/40	6/80	1/40
RashSkin and subcutaneous tissue disorders	0/121	5/80	0/40	1/77	0/39	0/80	0/40	6/80	0/40
HypertriglyceridaemiaMetabolism and nutrition disorders	8/121	0/80	0/40	3/77	1/39	0/80	0/40	3/80	1/40
Vessel Puncture Site BruiseGeneral disorders	6/121	5/80	1/40	0/77	0/39	0/80	0/40	5/80	1/40

Baseline characteristics

Overall safety population refers to all subjects who were exposed and randomized or exposed and not randomized.

Age, Continuous
Age, Continuous(Years)	CHTP 1.2	Cigarettes (CC)	Exposed Not Randomized	Total
Mean	38.9 ± 8.9	39.0 ± 8.0	28	38.8 ± 8.6

Sex: Female, Male
Sex: Female, Male(Participants)	CHTP 1.2	Cigarettes (CC)	Exposed Not Randomized	Total
Female	36	20	1	57
Male	44	20	0	64

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CHTP 1.2	Cigarettes (CC)	Exposed Not Randomized	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	80	40	0	120
More than one race	0	0	1	1
Unknown or Not Reported	0	0	0	0

BMI
BMI(kg/m2)	CHTP 1.2	Cigarettes (CC)	Exposed Not Randomized	Total
Mean	25.74 ± 3.51	25.70 ± 2.96	21.7	25.69 ± 3.33

Study locations

1 site

BioVirtus Research Site Sp. z o.o.
Nadarzyn, 05-830, Poland

References and documents

Publications

Bosilkovska M, Tran CT, de La Bourdonnaye G, Taranu B, Benzimra M, Haziza C. Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product. Toxicol Lett. 2020 Sep 15;330:30-40. doi: 10.1016/j.toxlet.2020.04.013. Epub 2020 May 5. PubMed 32380119 ↗

Study documents

Study protocol · Dec 5, 2016
Statistical analysis plan · Jan 27, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02641587
Lead sponsor: Philip Morris Products S.A.
Responsible party: Sponsor
First posted: Dec 29, 2015
Start date: Jan 2016
Primary completion: Aug 2016
Completion: Jul 2017
Results posted: Mar 6, 2019
Last update: Feb 21, 2023

Study contacts

Christelle Haziza, PhD

study chair · Philip Morris Products S.A.

Monika Tomaszewska-Kiecana, MD

principal investigator · BioVirtus Research Site

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

Study summary

Conditions studied

Browse trials for

Keywords

In context

Smoking

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria