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Pharmacokinetics and Pharmacodynamics of THS With LEVIA Compared to THS With TEREA and to Cigarettes
Sponsor: Philip Morris Products S.A.
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.
Official title: 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
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-02-01
Completion Date
2026-04-13
Last Updated
2026-03-10
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
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.
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.
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.
Locations (1)
BioResearch Group Sp. z o.o.
Nadarzyn, Poland