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

NCT07135648 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Nicotine

Interventions

OTHER

VM16

VM16 contains a liquid with a nicotine concentration of 1.6%

OTHER

VM32

VM32 contains a liquid with a nicotine concentration of 3.2%

OTHER

Cigarette (CC)

Subjects will provide their own usual brand of commercially available cigarettes

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Xavier Jaumont, MD · Philip Morris Products S.A.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2025-07-28
Completion
2025-10-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135648 on ClinicalTrials.gov