User Acceptability of a Nicotine Lactate Delivery System (P3L)

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: P3L; Other: VUSE; Other: CC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02643693

P3L-PK-02-US

Details and patient eligibility

About

This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with their own brand of CC or the VUSE e-cigarette system.

Full description

The total duration of the study for an individual subject will be between 3 and 8 weeks, including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the preference evaluation session (subjects will be given the choice of using ad libitum the P3L or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive safety follow-up period.

The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.

Enrollment: 24 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Smoking, healthy subject as judged by the Investigator
• Subject smoked at least 10 commercially available non-menthol CCs per day for the last 12 months
• Subject does not plan to quit smoking in the next 60 days

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 donated or been in receipt of whole blood or blood products within 3 months prior to the screening visit
• Subject has used tobacco products or nicotine containing products other than CCs within 30 days prior to the screening visit
• Female subject is pregnant or breast feeding
• Female subject does not agree to use an acceptable method of effective contraception
• Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

P3L Product use

Experimental group

Description:

Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).

Treatment:

Other: P3L

VUSE Product Use

Experimental group

Description:

Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).

Treatment:

Other: VUSE

CC Product Use

Experimental group

Description:

Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).

Treatment:

Other: CC