Status:
COMPLETED
Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants
Lead Sponsor:
Philip Morris Products S.A.
Conditions:
Vaping
Nicotine Absorption
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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..
Key Trial Info
Start Date :
July 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03379740
Start Date
July 11 2017
End Date
December 1 2017
Last Update
November 22 2019
Active Locations (1)
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1
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265