Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: CHTP 1.1 M; Other: mCC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02466412

P2M-PK-04-JP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 23+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

CHTP 1.1 M then mCC

Active Comparator group

Description:

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).

Treatment:

Other: CHTP 1.1 M

Other: mCC

mCC then CHTP 1.1 M

Active Comparator group

Description:

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).

Treatment:

Other: CHTP 1.1 M

Other: mCC