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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: NRT; Other: mCC; Other: mTHS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967706

ZRHM-PK-05-JP (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 73 patients

Sex: All

Ages: 23 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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73 participants in 4 patient groups

mTHS then mCC

Active Comparator group

Description:

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).

Treatment:

Other: mCC

Other: mTHS

mCC then mTHS

Active Comparator group

Description:

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).

Treatment:

Other: mCC

Other: mTHS

mTHS then NRT

Active Comparator group

Description:

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)

Treatment:

Other: NRT

Other: mTHS

NRT then mTHS

Active Comparator group

Description:

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).

Treatment:

Other: NRT

Other: mTHS