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Completed

NCT Number: NCT01959607

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

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.

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Key information

Conditions

Smoking Behavior

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi

Tokyo, 184-0005, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is Japanese.
  • Smoking, healthy subject as judged by the Investigator.
  • Subject smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks.
  • 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 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

THS 2.2

Other

Single use of the Tobacco Heating System 2.2 (THS 2.2)

CC

Other

Single use of subject's own cigarette (CC)

NRT Gum

Other

Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

Primary outcomes

  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT

    Time frame: 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.

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

    Time frame: 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 and Safety of THS 2.2 Following Single Use in Healthy Smokers Compared to Conventional Cigarettes and Nicotine Gum

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Jan 16, 2025

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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