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: mCC; Other: NNS; Other: mTHS 2.2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967719

ZRHM-PK-06-US (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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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64 participants in 4 patient groups

mTHS 2.2 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 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).

Treatment:

Other: mCC

Other: mTHS 2.2

mCC then mTHS 2.2

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 2.2).

Treatment:

Other: mCC

Other: mTHS 2.2

mTHS 2.2 then NNS

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

Treatment:

Other: mTHS 2.2

Other: NNS

NNS then mTHS 2.2

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 NNS) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS 2.2).

Treatment:

Other: mTHS 2.2

Other: NNS