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

NCT01967706 | Completed Results

• 1 other identifier: ZRHM-PK-05-JP
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).

Conditions

Smoking

Keywords

Smoking; Nicotine absorption; Candidate modified risk tobacco product; Cigarette; Nicotine replacement therapy; Nicotine gum

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

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

  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.

  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

Study Arms (4)

mTHS 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) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).

Other: mTHS; Other: mCC

mCC then mTHS

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).

Other: mTHS; Other: mCC

mTHS then NRT

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) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NRT)

Other: mTHS; Other: NRT

NRT then mTHS

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NRT) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS).

Other: mTHS; Other: NRT

Interventions

mTHS OTHER

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

NRT then mTHS; mCC then mTHS; mTHS then NRT; mTHS then mCC

mCC OTHER

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

mCC then mTHS; mTHS then mCC

NRT OTHER

Single administration of 2 mg gum (Nicorette® 2mg)

NRT then mTHS; mTHS then NRT

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is Japanese.
• Smoking, healthy subject as judged by the Investigator.
• Subject has smoked at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks.
• Subject has smoked for at least the last 3 consecutive years.
• Subject does not plan to quit smoking in the next 3 months.

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 medication (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)

Ageo Medical Clinic, 3133 Haraichi, Ageo-shi

Saitama, 362 0021, Japan

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle HAZIZA
• 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

• Fumimasa Nobuoka, MD

  Ageo Medical Clinic

  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: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 18, 2020
• Results First Posted: February 2, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)