N/A
Completed N=15
Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants
Vaping · Nicotine Absorption
Source: ClinicalTrials.gov NCT03379740 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Plasma Nicotine Concentration Versus Time Profile — 4.546; 3.165; 4.167; 7.518 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Nicotine Concentration Versus Time Profile |
4.546; 3.165; 4.167; 7.518; 6.782; 7.235 | — |
| PRIMARY Peak Plasma Nicotine Concentration [cCpeak] |
14.87; 13.32; 13.05; 26.47; 26.57 | — |
| PRIMARY Time to Peak Plasma Nicotine Concentration [Tpeak] |
60.000; 60.000; 60.000; 60.000; 60.000 | — |
| PRIMARY Background-corrected Trough Plasma Nicotine Concentration [cCtrough] |
3.492; 2.819; 2.905; 6.032; 4.845 | — |
| PRIMARY Background-corrected Average of Plasma Nicotine Concentration [cCaverage] |
8.548; 7.302; 7.870; 16.03; 14.48 | — |
| SECONDARY Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles |
1.228; 0.7868; 1.620; 2.025; 3.634; 3.158 | — |
| SECONDARY Background-corrected Maximum Plasma Concentration [cCmax] |
5.402; 5.074; 6.735; 9.437; 11.990 | — |
| SECONDARY Time to the Maximum Concentration [Tmax] |
10.002; 10.002; 7.002; 10.002; 7.002 | — |
| SECONDARY Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)] |
7.796; 6.969; 7.679; 11.55; 13.570; 33.77 | — |
| SECONDARY Subjective Effects of P4M3 Use |
4.76; 3.62; 3.49; 3.24; 3.04; 3.88 | — |
| SECONDARY Area Under the Curve of Craving for an Electronic Cigarette |
154.8; 134.4; 135.5; 141.8; 124.9; 143.2 | — |
| SECONDARY Sensory Parameters (Fixed Puffing Regimen) |
4.9; 3.7; 3.7; 3.5; 3.5; 3.6 | — |
| SECONDARY Sensory Parameters (ad Libitum Use) |
4.7; 3.9; 3.4; 3.6; 3.1; 3.1 | — |
| SECONDARY Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette |
1103.2913; 1133.2255; 1235.2367; 1139.8381; 935.8970; 2054.8081 | — |
Eligibility Criteria
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 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..
Data sourced from ClinicalTrials.gov (NCT03379740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.