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Completed

NCT Number: NCT01967719

Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)

The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).

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Key information

Conditions

Smoking Behavior

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is aged from 22 to 65 years (inclusive).
  • Smoking, healthy subject as judged by the Investigator.
  • Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
  • Subject has smoked for at least the last 3 consecutive years.

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

mTHS 2.2

Other

Single use of mTHS 2.2

mCC

Other

Single use of subject's own mCC

NNS

Other

Single administration of 1 mg of nicotine

Primary outcomes

  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS

    Time frame: 3 days

    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 (geometric LS) means are provided.

  2. Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS

    Time frame: 3 days

    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 and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Nasal Spray

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 23, 2013
Registry last updated
Mar 18, 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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