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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: CC; Other: THS 2.2; Other: NRT Gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959607

ZRHR-PK-02-JP (Other Identifier)

Details and patient eligibility

About

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.

Enrollment: 65 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 smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks.
• 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 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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65 participants in 4 patient groups

THS 2.2 then CC

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

Treatment:

Other: THS 2.2

Other: CC

CC then THS 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 CC) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of THS 2.2).

Treatment:

Other: THS 2.2

Other: CC

THS 2.2 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 THS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NRT gum \[Nicorette® 2mg\]).

Treatment:

Other: NRT Gum

Other: THS 2.2

NRT then THS 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 NRT gum \[Nicorette® 2mg\]) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of THS 2.2).

Treatment:

Other: NRT Gum

Other: THS 2.2