Status:
COMPLETED
Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
Lead Sponsor:
Philip Morris Products S.A.
Conditions:
Nicotine Vaping
Nicotine
Eligibility:
All Genders
24-65 years
Phase:
NA
Brief Summary
This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants...
Detailed Description
The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum...
Eligibility Criteria
Inclusion
- Subject has signed the ICF and is able to understand the information provided in the ICF.
- Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
- Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
- Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
- Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
Exclusion
- As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
- Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
- BMI \< 18.5 kg/m2 or \> 35.0 kg/m2.
- Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer), which has an impact on CYP2A6 activity.
- Subject has a positive serology test for HIV 1/2, Hepatitis B or Hepatitis C.
- Subject has a history of alcohol abuse that could interfere with the subject's participation in study.
- Subject has a positive urine drug test.
- Subject has a positive alcohol breath test.
- Subject has participated in another clinical study within 30 days prior to the Screening Visit.
- Subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is breastfeeding.
- For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05383508
Start Date
April 28 2022
End Date
August 25 2022
Last Update
April 26 2024
Active Locations (1)
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1
High Point Clinical Trials Center (HPCTC)
High Point, North Carolina, United States, 27265