N/A N=80 Randomized Other

Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.

Smoking

Bottom Line

View on ClinicalTrials.gov: NCT02503254 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Mar 2017

Primary outcome: Primary: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) — 327.08; 1903.61 pg/mg creat — p=<.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CHTP 1.0 (Other); Conventional Cigarette (CC) (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Philip Morris Products S.A.
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)	327.08; 1903.61	<.001 sig
PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	464.27; 1272.96	<0.001 sig
PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA)	352.39; 2971.98	<.001 sig
PRIMARY Levels of Carboxyhemoglobin (COHb)	2.660; 6.460	<.001 sig

Summary

The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.

Eligibility Criteria

Inclusion Criteria

Subject is aged ≥ 21 years.
Subject is Caucasian.
Subject is healthy, as judged by the Investigator.
Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
Subject has smoked at least for the last 3 years.
Subject does not plan to quit smoking in the next 3 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.

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Data sourced from ClinicalTrials.gov (NCT02503254). 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.