Nicotine PK & PD Study of Heated Products compared to Cigarettes

• Research type

  Research Study

• Full title

  A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco and Heated Herbal Products Compared with Combustible Cigarettes

• IRAS ID

  331325

• Contact name

  Devinda Weeraratne

• Contact email

  devinda.weeraratne@celerion.com

• Sponsor organisation

  Imperial Brands PLC

• Clinicaltrials.gov Identifier

  NCT06093659

• Duration of Study in the UK

  0 years, 1 months, 4 days

• Research summary

  This clinical study aims to evaluate and compare the maximum plasma nicotine concentration (Cmax) and the area under the plasma nicotine concentration-time curve at the last time point measured (AUCt) following use of each Heated Tobacco Product, Heated Herbal Product, or cigarette comparator.

  The study will investigate combustible cigarettes, heated tobacco products (HTPs), and Heated Herbal Products (HHPs), in a cross-over design, incorporating PK evaluation, subjective effects assessments, usage behaviour, and puff topography.

  The study will also incorporate a product use safety evaluation.

• REC name

  HSC REC A

• REC reference

  23/NI/0099

• Date of REC Opinion

  14 Sep 2023

• REC opinion

  Further Information Favourable Opinion