Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P
2020. január 21. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
19
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
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Ticino
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Arzo, Ticino, Svájc, 6864
- CROSS Research
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
21 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: 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 |
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
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Aktív összehasonlító: 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 |
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
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Aktív összehasonlító: 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 |
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
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Aktív összehasonlító: 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 |
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|
Aktív összehasonlító: 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 |
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
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Aktív összehasonlító: 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 |
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Plasma Nicotine Concentration-time Profile
Időkeret: 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.
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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
|
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Maximum Plasma Concentration [Cmax]
Időkeret: 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.
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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
|
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Time to the Maximum Nicotine Concentration [Tmax]
Időkeret: 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.
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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
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Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Plasma Nicotine Concentration-time Profile
Időkeret: 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.
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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
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Peak Plasma Nicotine Concentration [Cpeak]
Időkeret: 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
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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
|
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Time to Peak Plasma Nicotine Concentration [Tpeak]
Időkeret: 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
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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.
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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
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Trough Plasma Nicotine Concentration [Ctrough]
Időkeret: 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
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To measure the trough plasma nicotine concentration [Ctrough] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
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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
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Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]
Időkeret: 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
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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
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Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)]
Időkeret: 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
Időkeret: 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
|
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AUC Craving for a Cigarette During and After the ad Libitum Use Period
Időkeret: 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
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Product Evaluation
Időkeret: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
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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).
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Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
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Sensory Parameters
Időkeret: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
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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).
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Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
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Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.
Időkeret: During fixed puffing product use on days 1, 2, 3 and 4
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Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period.
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During fixed puffing product use on days 1, 2, 3 and 4
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Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.
Időkeret: During ad libitum product use on days 1, 2, 3 and 4
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Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period.
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During ad libitum product use on days 1, 2, 3 and 4
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Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Időkeret: Before and after fixed puffing product use on days 1, 2, 3 and 4
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Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen.
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Before and after fixed puffing product use on days 1, 2, 3 and 4
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Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
Időkeret: Before and after ad libitum product use on days 1, 2, 3 and 4
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P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used).
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Before and after ad libitum product use on days 1, 2, 3 and 4
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Milko Radicioni, MD, CROSS Research, Arzo, Ticino, Switzerland
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2017. november 7.
Elsődleges befejezés (Tényleges)
2018. február 1.
A tanulmány befejezése (Tényleges)
2018. május 2.
Tanulmányi regisztráció dátumai
Először benyújtva
2017. november 22.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2017. december 5.
Első közzététel (Tényleges)
2017. december 12.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. január 31.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. január 21.
Utolsó ellenőrzés
2020. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- P3P-PK-01-CH
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .