NCT07459712

Pharmacokinetics and Pharmacodynamics of THS With LEVIA Compared to THS With TEREA and to Cigarettes

A Single-center, Randomized, Controlled, Openlabel, Cross-over Study in Currently Smoking Adult Participants to Investigate the Nicotine Pharmacokinetics and Pharmacodynamics of Tobacco Heating System (THS) With LEVIA, a Tobacco-free Nicotine-containing Product Compared to THS With TEREA, a Heated Tobacco Product and to Cigarettes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, controlled, open-label, crossover study in currently smoking adult participants to investigate the nicotine pharmacokinetics and pharmacodynamics of Tobacco Heating System (THS) with LEVIA, a tobacco-free nicotine-containing consumable, compared to THS with TEREA, a tobacco-containing consumable, and cigarettes. The study will use a 2-period, 2-sequence design for the ad libitum use days, and a 3-period, 6-sequence Williams design for the single-use days. Across the ad libitum use and single-use period, this is a design with 5 periods and 12 sequences.

Conditions

• Nicotine

Interventions

Type	Name	Description
OTHER	THS with LEVIA (ad libitum)	On Day 1 through Day 2, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use THS with LEVIA ad libitum in the randomized product-use sequence. The ad libitum use period will last approximately 12 hours.
OTHER	THS with TEREA (ad libitum)	On Day 1 through Day 2, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use THS with TEREA ad libitum in the randomized product-use sequence. The ad libitum use period will last approximately 12 hours.
OTHER	THS with LEVIA	On Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use a single THS with LEVIA in the randomized product-use sequence, as instructed by the investigational site staff.
OTHER	THS with TEREA	On Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use a single THS with TEREA in the randomized product-use sequence, as instructed by the investigational site staff.
OTHER	Cigarette	On Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use their usual brand of cigarettes according to the randomized product-use sequence and as instructed by the investigational site staff.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-02-09
• Completion: 2026-04-13
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Poland