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Completed

NCT Number: NCT01959932

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

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).

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Key information

Conditions

Smoking Behavior

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioVirtus Research Site Sp. z o.o.

Kajetany, 05-830, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tobacco Heating System (THS 2.2)

Other

THS 2.2 ad libitum for 5 days in confinement

Smoking Abstinence (SA)

Other

SA for 5 days in confinement

Conventional Cigarette (CC)

Other

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Primary outcomes

  1. Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

    Time frame: 5 days

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

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

  2. Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

    Time frame: 5 days

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

    Geometric Least Squares means are provided as descriptive statistics.

  3. Concentration of S-phenylmercapturic Acid (S-PMA)

    Time frame: 5 days

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

    Geometric Least Squares means are provided as descriptive statistics.

  4. Levels of Carboxyhemoglobin (COHb)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study title

A Randomized, Controlled, Open-label, 3-arm Parallel Group, Single-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smoking, Healthy Subjects Switching to the Tobacco Heating System 2.2 (THS 2.2) or Smoking Abstinence, Compared to Continuing to Use Conventional Cigarettes, for 5 Days in Confinement.

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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