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Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

21 stycznia 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

19

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Szwajcaria
    • Ticino
      • Arzo, Ticino, Szwajcaria, 6864
        • CROSS Research

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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
Inny: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Aktywny komparator: 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
Inny: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Aktywny komparator: 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
Inny: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Aktywny komparator: 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
Inny: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Aktywny komparator: 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
Inny: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Aktywny komparator: 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
Inny: P3P 1
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 2
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 3
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
Inny: P3P 4
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Plasma Nicotine Concentration-time Profile
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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)]
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Plasma Nicotine Concentration-time Profile
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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)]
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Philip Morris Products S.A.

Śledczy

  • Główny śledczy: Milko Radicioni, MD, CROSS Research, Arzo, Ticino, Switzerland

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

7 listopada 2017

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2018

Ukończenie studiów (Rzeczywisty)

2 maja 2018

Daty rejestracji na studia

Pierwszy przesłany

22 listopada 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 grudnia 2017

Pierwszy wysłany (Rzeczywisty)

12 grudnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

31 stycznia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 stycznia 2020

Ostatnia weryfikacja

1 stycznia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • P3P-PK-01-CH

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Warunki

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Lokalizacje

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