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OpenTrials
Completed

NCT Number: NCT02503254

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

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.

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Key information

Conditions

Smoking Behavior

Age range

21 year and older

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 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.

Treatment and study plan

CHTP 1.0

Other

CHTP 1.0 ad libitum 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 on 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 on 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 on 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, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Jan 30, 2023

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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