N/A N=120 Randomized Other

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

Smoking

Bottom Line

View on ClinicalTrials.gov: NCT02641587 ↗

Enrolled (actual)

120

Serious AEs

1.0%

Results posted

Mar 2019

Primary outcome: Primary: Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA) — 285.5; 1904 pg/mg creat — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CHTP 1.2 (Other); CC (Other)
Age: Adult, Older Adult · 28+ yrs
Sex: All
Sponsor: Philip Morris Products S.A.
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)	285.5; 1904	<0.001 sig
PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	616.8; 1031	<0.001 sig
PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA)	386.6; 2401	<0.001 sig
PRIMARY Levels of Carboxyhemoglobin (COHb)	2.01; 4.53	<0.001 sig
PRIMARY Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)	37.26; 180.6	<0.001 sig

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.

Eligibility Criteria

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02641587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.