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Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

Not Applicable
Completed
Conditions
Smoking
Registration Number
NCT01959932
Lead Sponsor
Philip Morris Products S.A.
Brief Summary

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
169
Inclusion Criteria
  • Subject is Caucasian.
  • Current healthy smoker as judged by the Principal Investigator.
  • Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
  • Subject has smoked for at least the last 3 consecutive 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)5 days

Concentrations measured at Day 5 in urine, adjusted for creatinine.

Geometric Least Squares means are provided as descriptive statistics.

Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)5 days

Concentrations measured at Day 5 in urine, adjusted for creatinine.

Geometric Least Squares (LS) means are provided as descriptive statistics.

Concentration of S-phenylmercapturic Acid (S-PMA)5 days

Concentrations measured at Day 5 in urine, adjusted for creatinine.

Geometric Least Squares means are provided as descriptive statistics.

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 means are provided as descriptive statistics.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

BioVirtus Research Site Sp. z o.o.

🇵🇱

Kajetany, Poland

BioVirtus Research Site Sp. z o.o.
🇵🇱Kajetany, Poland

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