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

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

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.

Sponsors & Collaborators

• Philip Morris Products S.A.

  lead INDUSTRY

Principal Investigators

• Christelle Haziza, PhD · Philip Morris Products S.A.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2026-02-09

Completion

2026-04-14

Countries

• Poland

Study Locations