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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: CHTP 1.2; Other: CC

• Registration Number: NCT02641587
• Lead Sponsor: Philip Morris Products S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Study Start: 2016-01
• Primary Completion: 2016-08
• Study Completion: 2017-07
• Results First Submitted: 2018-10-02
• Results First Submitted QC: 2019-03-05
• Results First Posted: 2019-03-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHTP 1.2	CHTP 1.2	Ad libitum use of the CHTP 1.2
CC	CC	Ad libitum use of subject's own preferred non-menthol brand of CC

Primary Outcome Measures

Name	Time	Method
Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)	5 days	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.
Levels of Carboxyhemoglobin (COHb)	5 days	% 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.
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	5 days	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.
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)	90 days	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.
Concentration of S-phenylmercapturic Acid (S-PMA)	5 days	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.

Trial Locations

Locations (1)

BioVirtus Research Site Sp. z o.o.; 🇵🇱 Nadarzyn, Poland