Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants

Completed · Not applicable

Conditions studied: Vaping, Nicotine Absorption

In brief

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.

Key facts

Study ID

NCT03379740

Run by

Philip Morris Products S.A.

People needed

15

Starts

2017-07-11

Expected to finish

2017-12-01

Last updated by the study team

2019-11-22

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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..

Where it is running

• High Point Clinical Trials Center — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.