Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2018-05-02

Brief Summary

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This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

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COMPLETED PHASE1

Detailed Description

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The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two different nicotine aersol particle sizes and presence/absence of a flavoring system will be tested to identify which one would yield plasma nicotine concentrations as close as possible to those achieved after smoking a single cigarette. All of the subjects will initially use the lowest nicotine content product (P3P 3). Subject will continue the study using the three remaining products (P3P 1, P3P 2 and P3P 4) containing 2 mg nicotine/product in a randomly assigned sequence.

Two product use regimens: fixed puffing and ad libitum use will be applied to provide insight into nicotine absorption. The fixed puffing regimen with consistent use conditions across subjects will be applied in order to minimize variability. The 1 hour ad libitum use period will provide information on nicotine PK and product acceptance when subjects use the P3P according to their own puffing behavior which is closer to a real-world setting.

Safety and tolerability will also be assessed throughout the study.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A single-center, open-label, randomized, crossover study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Sponsor staff, Investigator, the subjects and the investigational site will be blinded to the randomization sequences until they are assigned. Subjects will not be informed of the complete sequence to which they have been assigned.

Study Groups

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Product Sequence 1

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of:

P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4

Group Type ACTIVE_COMPARATOR

P3P 1

Intervention Type OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 2

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 3

Intervention Type OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 4

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Product Sequence 2

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of:

P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4

Group Type ACTIVE_COMPARATOR

P3P 1

Intervention Type OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 2

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 3

Intervention Type OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 4

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Product Sequence 3

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of:

P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4

Group Type ACTIVE_COMPARATOR

P3P 1

Intervention Type OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 2

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 3

Intervention Type OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 4

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Product Sequence 4

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of:

P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4

Group Type ACTIVE_COMPARATOR

P3P 1

Intervention Type OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 2

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 3

Intervention Type OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 4

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Product Sequence 5

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of:

P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4

Group Type ACTIVE_COMPARATOR

P3P 1

Intervention Type OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 2

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 3

Intervention Type OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 4

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Product Sequence 6

Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of:

P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4

Group Type ACTIVE_COMPARATOR

P3P 1

Intervention Type OTHER

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 2

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 3

Intervention Type OTHER

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

P3P 4

Intervention Type OTHER

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Interventions

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P3P 1

2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm

Intervention Type OTHER

P3P 2

2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

Intervention Type OTHER

P3P 3

1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm

Intervention Type OTHER

P3P 4

2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
* Subject is between 21 and 65 years old.
* Subject is Caucasian.
* Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
* Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).
* Subject has been smoking for at least the last 3 years prior to Screening Visit.
* Subject does not plan to quit smoking in the next 2 months after the Screening Visit.