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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03379740
Other study ID # P4M3-PK-02-US
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 11, 2017
Est. completion date December 1, 2017

Study information

Verified date November 2019
Source Philip Morris Products S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-center, open-label, concentration-ranging study to evaluate the nicotine PK profile and PD effects in healthy adult experienced users of closed tank/cartridge e-cigarettes using four different variants of P4M3 (nicotine concentration of 1.7%, 1.7% with 1.1% lactic acid [LA], 3% with 1.1% LA, and 4% with 2% LA) or their own e-cigarettes.


Description:

The goal of the study is to evaluate the nicotine concentration profiles and derived PK parameters, subjective effects, behavioral parameters, including puffing topography parameters of P4M3 with four different variants of P4M3, in experienced e-cigarette users after a single-use experience with fixed puffing regime and after ad libitum use of P4M3.

Four variants of P4M3 will be evaluated together with subjects' own e-cigarettes to evaluate the relationship between the e-liquid composition (nicotine concentrations and presence of lactic acid) and the amount of nicotine absorbed, the speed of absorption, and the puffing topography.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 1, 2017
Est. primary completion date August 14, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- Subject has signed the informed consent form (ICF) and is able to understand the information provided in the ICF.

- Subject is 21 to 65 years of age, inclusive, at the Screening Visit.

- Subject is a former daily cigarette smoker who smoked at least 100 cigarettes or more in his/her life and ceased smoking at least 3 months prior to the Screening Visit.

- Subject has been using a commercially available, nicotine-containing closed tank/cartridge e-cigarette daily for at least 3 months prior to the Screening Visit.

- Subject has a urine cotinine test =200 ng/mL at the Screening Visit and Admission.

Exclusion Criteria:

- Subject has a clinically relevant disease which requires medication which as per the judgment of the Investigator would jeopardize the safety of the subject.

- Subject has abnormal renal function test result or subject with a creatinine clearance <60 mL/minute at the Screening Visit, confirmed on repeat testing.

- Subject has elevated liver function test results at the Screening Visit.

- Subject has bilirubin >1.5X ULN at the Screening Visit.

- Subject has FEV1/FVC <0.7 and FEV1 <80% predicted value at post-bronchodilator spirometry at the Screening Visit.

- Subject has asthma condition at the Screening Visit.

- Subject has received medication within 14 days or within 5 half-lives of the drug (whichever is longer) prior to Admission, which has an impact on cytochrome P450 (CYP) 2A6 activity.

- Subject has a carbon monoxide (CO) breath test = 10 ppm at the Screening Visit or Admission.

- Subject has a body mass index (BMI) <18.5 kg/m2 or BMI =35 kg/m2 at the Screening Visit.

- Subject has a positive serology test for human immunodeficiency virus (HIV) 1/2, hepatitis B, or hepatitis C at the Screening Visit.

- Subject has clinically significant ECG findings at the Screening Visit.

- Subject has participated in a clinical study within 3 months prior to the Screening Visit.

- Subject smokes cigarettes or uses other tobacco products.

- Female subject of childbearing potential who is pregnant or breastfeeding.

- Female subject of childbearing potential who does not agree to use an acceptable method of effective contraception..

Study Design


Related Conditions & MeSH terms


Intervention

Other:
E-cigarette
Subject's own e-cigarette
P4M3-1.7%
P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3-1.7%LA
P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
P4M3-3%LA
P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3-4%LA
P4M3 e-liquid concentration of 4% nicotine with lactic acid

Locations

Country Name City State
United States High Point Clinical Trials Center High Point North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma Nicotine Concentration Versus Time Profile To measure total and background-corrected plasma nicotine concentration versus time profiles from 60 minutes of ad libitum use. From Day -1 (baseline) to Day 4
Primary Peak Plasma Nicotine Concentration [cCpeak] To measure background-corrected peak plasma nicotine concentration [cCpeak] from 60 minutes of ad libitum use. From Day -1 (baseline) to Day 4
Primary Time to Peak Plasma Nicotine Concentration [Tpeak] To measure the time to peak plasma nicotine concentration [tpeak] from 60 minutes of ad libitum use. From Day -1 (baseline) to Day 4
Primary Background-corrected Trough Plasma Nicotine Concentration [cCtrough] To measure background-corrected trough plasma nicotine concentration [cCtrough] from 60 minutes of ad libitum use. From Day -1 (baseline) to Day 4
Primary Background-corrected Average of Plasma Nicotine Concentration [cCaverage] To measure background-corrected average of plasma nicotine concentration between 0 to 1 hour [cCaverage] from 60 minutes of ad libitum use. From Day -1 (baseline) to Day 4
Secondary Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles To measure the total and background-corrected plasma nicotine concentration versus time profiles of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen. From Day -1 (baseline) to Day 4
Secondary Background-corrected Maximum Plasma Concentration [cCmax] To measure the background-corrected maximum plasma concentration [cCmax] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen. From Day -1 (baseline) to Day 4
Secondary Time to the Maximum Concentration [Tmax] To measure the time to the maximum concentration [tmax] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen. From Day -1 (baseline) to Day 4
Secondary Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)] To measure the background-corrected area under the concentration-time curve, which is above the corrected baseline from the start of product use to 4 hours [cAUC(0-4h)], of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen. From Day -1 (baseline) to Day 4
Secondary Subjective Effects of P4M3 Use Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) within 60 minutes after the ad libitum use session. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). From Day -1 (baseline) to Day 4
Secondary Area Under the Curve of Craving for an Electronic Cigarette Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving), before and after the fixed puffing regimen and ad libitum use period. (The VAS craving was measured from 0 to 100 on a 100 mm scale.)
The data below present the Area under the VAS craving score-time curve from the start of product use to 4 hours.
The area under the curve for VAS craving is an integrated measurement of the VAS craving taking into account several timepoints. AUC was calculated using a trapezoidal rule between timepoints without normalization.
From Day -1 (baseline) to Day 4
Secondary Sensory Parameters (Fixed Puffing Regimen) Measured with a Sensory Questionnaire (SQ) within 60 minutes after each fixed puffing regimen use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). From Day 1 to Day 4
Secondary Sensory Parameters (ad Libitum Use) Measured with a Sensory Questionnaire (SQ) within 60 minutes after each ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely). From Day 1 to Day 4
Secondary Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette Total Puff Volume measured for the P4M3 variants and the subjects' own e-cigarette from the fixed puffing regimen and the 60 minutes ad libitum use. From Day -1 (baseline) to Day 4
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