Nicotine PK, PD & subjective effects of THS compared to cigarettes

• Research type

  Research Study

• Full title

  A single-center, randomized, controlled, open-label, cross-over study in healthy 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

• IRAS ID

  353331

• Contact name

  Xavier Jaumont

• Contact email

  xavier.jaumont@pmi.com

• Sponsor organisation

  Philip Morris Products S.A

• Duration of Study in the UK

  0 years, 0 months, 16 days

• Research summary

  A single-center, randomized, controlled, open-label, cross-over study in healthy 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. The participants will be blinded to the randomized product use sequences.
  The study will be conducted with 2 periods and 2 sequences for the ad libitum use days and with 3 periods and 6 sequences in a Williams design for single use days.

  
  

• REC name

  HSC REC B

• REC reference

  25/NI/0012

• Date of REC Opinion

  18 Feb 2025

• REC opinion

  Unfavourable Opinion