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Completed

NCT Number: NCT02466412

Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.

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Key information

Conditions

Smoking Behavior

Age range

23 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ageo Medical Clinic

Saitama, 362-0021, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is Japanese.
  • Subject is at a minimum 23 years of age.
  • Smoking, healthy subject as judged by the Investigator.
  • Subject has smoked for at least the last 3 years
  • Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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 a drug (whichever is longer) which has an impact on 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 1.1 M

Other

Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

mCC

Other

Single use of subject's own menthol conventional cigarette (mCC)

Primary outcomes

  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC

    Time frame: Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.

    T0 = start of single product use.

    Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).

    Geometric Least Squares (LS) means are provided.

  2. Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC

    Time frame: Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.

    T0 = start of single product use.

    Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).

    Geometric Least Squares means are provided.

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study title

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
May 13, 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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