Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

21 января 2020 г. обновлено: Philip Morris Products S.A.

A Single-center, Open-label, Randomized, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile, Pharmacodynamics, Safety and Tolerability of Four P3P Variants in Smoking Healthy Adult Subjects

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

19

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 21 год до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Exclusion criteria:

  • Female subject is pregnant or breastfeeding.
  • Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 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
Другой: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Активный компаратор: 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
Другой: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Активный компаратор: 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
Другой: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Активный компаратор: 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
Другой: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Активный компаратор: 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
Другой: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Активный компаратор: 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
Другой: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Другой: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Plasma Nicotine Concentration-time Profile
Временное ограничение: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
Maximum Plasma Concentration [Cmax]
Временное ограничение: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the maximum nicotine plasma concentration [Cmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
Time to the Maximum Nicotine Concentration [Tmax]
Временное ограничение: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the time to maximum nicotine concentration [Tmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]
Временное ограничение: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Plasma Nicotine Concentration-time Profile
Временное ограничение: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
To measure the plasma nicotine concentration-time profile of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Peak Plasma Nicotine Concentration [Cpeak]
Временное ограничение: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
To measure the Peak plasma nicotine concentration [Cpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Time to Peak Plasma Nicotine Concentration [Tpeak]
Временное ограничение: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
To measure the time to peak plasma nicotine concentration [Tpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Trough Plasma Nicotine Concentration [Ctrough]
Временное ограничение: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
To measure the trough plasma nicotine concentration [Ctrough] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]
Временное ограничение: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4
To measure the average of plasma nicotine concentration [Caverage], of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels
Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4
Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)]
Временное ограничение: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
To measure the area under the plasma concentration-time curve of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen
Временное ограничение: During and up to 4 hours post-product use on days 1, 2, 3 and 4
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).
During and up to 4 hours post-product use on days 1, 2, 3 and 4
AUC Craving for a Cigarette During and After the ad Libitum Use Period
Временное ограничение: During and up to 4 hours post-product use on days 1, 2, 3 and 4
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).
During and up to 4 hours post-product use on days 1, 2, 3 and 4
Product Evaluation
Временное ограничение: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) following the ad libitum use period. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Sensory Parameters
Временное ограничение: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Measured with a Sensory Questionnaire (SQ) following the ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.
Временное ограничение: During fixed puffing product use on days 1, 2, 3 and 4
Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period.
During fixed puffing product use on days 1, 2, 3 and 4
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.
Временное ограничение: During ad libitum product use on days 1, 2, 3 and 4
Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period.
During ad libitum product use on days 1, 2, 3 and 4
Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Временное ограничение: Before and after fixed puffing product use on days 1, 2, 3 and 4
Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen.
Before and after fixed puffing product use on days 1, 2, 3 and 4
Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
Временное ограничение: Before and after ad libitum product use on days 1, 2, 3 and 4
P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used).
Before and after ad libitum product use on days 1, 2, 3 and 4

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Philip Morris Products S.A.

Следователи

  • Главный следователь: Milko Radicioni, MD, CROSS Research, Arzo, Ticino, Switzerland

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

7 ноября 2017 г.

Первичное завершение (Действительный)

1 февраля 2018 г.

Завершение исследования (Действительный)

2 мая 2018 г.

Даты регистрации исследования

Первый отправленный

22 ноября 2017 г.

Впервые представлено, что соответствует критериям контроля качества

5 декабря 2017 г.

Первый опубликованный (Действительный)

12 декабря 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

31 января 2020 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 января 2020 г.

Последняя проверка

1 января 2020 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • P3P-PK-01-CH

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования P3P 1

Искать похожие исследования

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

CROs by country

CROs in Tanzania

Заболевания

Редкие заболевания

Медикаментозные вмешательства

Пищевые добавки

Спонсор / Соавторы

Места

Подписаться