Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

NCT02466412 | Completed Results

• 1 other identifier: P2M-PK-04-JP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.

Conditions

Smoking

Keywords

smoking; nicotine absorption; potential modified risk tobacco product; cigarette; Carbon Heated Tobacco Product

Outcome Measures

Primary Outcomes (2)

• Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC

  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 (LS) means are provided.

  Day 3: 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 Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC

  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.

  Day 3: 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 (2)

CHTP 1.1 M then mCC

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day -1 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of CHTP 1.1 M) * Day 2 = Wash-out * Day 3 = 2nd intervention (single product use of mCC).

Other: CHTP 1.1 M; Other: mCC

mCC then CHTP 1.1 M

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day -1 = 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 CHTP 1.1 M).

Other: CHTP 1.1 M; Other: mCC

Interventions

CHTP 1.1 M OTHER

Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

CHTP 1.1 M then mCC; mCC then CHTP 1.1 M

mCC OTHER

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

CHTP 1.1 M then mCC; mCC then CHTP 1.1 M

Eligibility Criteria

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

You may qualify if:

• Subject is Japanese.
• Subject is at a minimum 23 years of age.
• Smoking, healthy subject as judged by the Investigator.
• Subject has smoked for at least the last 3 years
• Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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)

Ageo Medical Clinic

Saitama, 362-0021, Japan

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Steffen Fredersdorf
• Organization: Philip Morris Products S.A.

Steffen.Fredersdorf@pmi.com

+41 (58) 242 2182

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: May 7, 2015
• First Posted: June 9, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 13, 2020
• Results First Posted: April 11, 2017

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)