Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of VM 1.0 Compared to Cigarettes in Adult Current Smokers

Philip Morris

Status: Active, not recruiting

Conditions: Nicotine

Treatments: Other: VM16; Other: VM32; Other: Cigarette (CC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07135648

NS-VM-PK-01

Details and patient eligibility

About

A single-center, randomized, controlled, partially blinded, crossover study to evaluate the pharmacokinetics and pharmacodynamics of nicotine following use of two variants of VM 1.0, VM16 and VM32, a nicotine-containing aerosol generator compared to cigarettes in adult current smokers. The participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. The study will be conducted with 3 periods and 3 sequences.

Enrollment: 16 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant has signed the ICF and is able to understand the information provided in the ICF.
• Male or female participant between 21 and 65 years inclusive.
• Participant has smoked commercially available or roll-your own cigarettes (no brand restrictions) for at least the last 12 months prior to the Screening visit.
• Participant has smoked at least 10 commercially available cigarettes per day in the past 30 days prior to the Screening visit and Admission.
• Nicotine exposure status will be verified by urinary cotinine test (cotinine ≥ 200 ng/mL).
• Participant has a BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Participant is available for the entire study period and willing to comply with study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco containing products and willing to adhere to a standardized diet.

Exclusion criteria

• Participant has reasons other than medical (e.g., psychological, social reason) not to be part of the study, as determined by the Principal Investigator or designee.
• Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners).
• Participant has a health condition which requires medication or any other clinically significant finding e.g., safety labs, pulmonary function test, vital signs, physical examination, ECG and medical history, as determined by the Principal Investigator or designee.
• Participant experiences difficulty with venipuncture and/or poor venous access.
• Participant has medical conditions which require, or will require during the study, a medical intervention (e.g., start of treatment, surgery, hospitalization).
• Presence of fever (body temperature >37.5°C) e.g., a fever associated with a symptomatic viral or bacterial infection.
• Participant has a hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening visit.
• Participant uses medication that aids in smoking cessation.
• Participant uses Tetrahydrocannabinol (THC)-containing products.
• Participant previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to Admission.
• Participant has donated plasma within seven days prior to screening or has donated or lost 450 mL or more of whole blood within 8 weeks prior to Screening for males, and in the 12 weeks prior to the Screening visit for females.
• Participant has a positive serology test for HIV 1/2, hepatitis B or C.
• Participant has a medical history of alcohol abuse within one year prior to Screening or regular use of alcohol within six months prior to the Screening visit that exceeds 10 units for women or 15 units for men of alcohol per week.
• Participant has a positive urine drug test.
• Participant has a positive alcohol breath test.
• Participant or one of their family members is a current or former employee of the tobacco industry.
• Participant or one of their family members is an employee of the investigational site or of any other parties involved in the study.
• Participant has participated in another clinical study within 30 days prior to the Screening visit or concomitantly participates in any other investigational study.
• Participant has been previously screened or enrolled in this study (except alternates)
• For female participants only: participant has a positive urine pregnancy test at the Screening visit or at Admission or is a breastfeeding.
• For females of childbearing potential only: participant does not agree to use an acceptable method of effective contraception.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 3 patient groups

Product Sequence 1

Active Comparator group

Description:

On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette

Treatment:

Other: VM32

Other: VM16

Other: Cigarette (CC)

Product Sequence 2

Active Comparator group

Description:

On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette

Treatment:

Other: VM32

Other: VM16

Other: Cigarette (CC)

Product Sequence 3

Active Comparator group

Description:

On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette

Treatment:

Other: VM32

Other: VM16

Other: Cigarette (CC)