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

NCT01967719 | Completed Results

• 1 other identifier: ZRHM-PK-06-US
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Smoking

Keywords

Smoking; Nicotine absorption; Candidate modified risk tobacco product; Conventional cigarette; Nicotine replacement therapy: nasal spray

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Study Arms (4)

mTHS 2.2 then mCC

ACTIVE COMPARATOR

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; Other: mCC

mCC then mTHS 2.2

ACTIVE COMPARATOR

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; Other: mCC

mTHS 2.2 then NNS

ACTIVE COMPARATOR

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: mTHS 2.2; Other: NNS

NNS then mTHS 2.2

ACTIVE COMPARATOR

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: mTHS 2.2; Other: NNS

Interventions

mTHS 2.2 OTHER

Single use of mTHS 2.2

NNS then mTHS 2.2; mCC then mTHS 2.2; mTHS 2.2 then NNS; mTHS 2.2 then mCC

mCC OTHER

Single use of subject's own mCC

mCC then mTHS 2.2; mTHS 2.2 then mCC

NNS OTHER

Single administration of 1 mg of nicotine

NNS then mTHS 2.2; mTHS 2.2 then NNS

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle HAZIZA, PhD
• Organization: Philip Morris Products S.A.

Christelle.Haziza@pmi.com

+41 (58) 242 2625

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

• James L Borders, MD

  Central Kentucky Research Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 18, 2020
• Results First Posted: February 7, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)