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

March 9, 2020 updated by: Philip Morris Products S.A.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mTHS 2.2 then mCC

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mTHS 2.2)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mCC).
Other: mTHS 2.2
Single use of mTHS 2.2
Other: mCC
Single use of subject's own mCC
Active Comparator: mCC then mTHS 2.2

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mCC)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mTHS 2.2).
Other: mTHS 2.2
Single use of mTHS 2.2
Other: mCC
Single use of subject's own mCC
Active Comparator: mTHS 2.2 then NNS

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mTHS 2.2)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single administration of NNS)
Other: NNS
Single administration of 1 mg of nicotine
Other: mTHS 2.2
Single use of mTHS 2.2
Active Comparator: NNS then mTHS 2.2

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single administration of NNS)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mTHS 2.2).
Other: NNS
Single administration of 1 mg of nicotine
Other: mTHS 2.2
Single use of mTHS 2.2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philip Morris Products S.A.

Investigators

  • Principal Investigator: James L Borders, MD, Central Kentucky Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZRHM-PK-06-US (Other Identifier: Philip Morris Products S.A.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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