NCT07135648

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

A Single-center, Randomized, Controlled, Partially Blinded, Crossover Study to Evaluate the Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of Vibrating Mesh 1.0 (VM 1.0), a Nicotine-containing Aerosol Generator, Compared to Cigarettes in Adult Current Smokers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-07-17
• Primary completion: 2025-07-28
• Completion: 2025-10-06
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: United Kingdom