Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)

Smoking Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967732
• Other study ID #: ZRHR-PK-01-EU
• Secondary ID: ZRHR-PK-01-EU201
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2020
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject is Caucasian

• Smoking, healthy subject as judged by the Investigator.

• Subject has smoked at least 10 commercially available non menthol CCs per day (no brand restrictions) for the last 4 weeks.

• Subject has smoked for at least the last 3 consecutive years.

• Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

• As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).

• Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.

• Female subject is pregnant or breast feeding.

• Female subject does not agree to use an acceptable method of effective contraception.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)
• CC
Single use of subject's own conventional cigarette (CC)
• NNS
Single administration of 1 mg of nicotine

Locations

Country	Name	City	State
United Kingdom	Celerion GB Ltd, 22-24 Lisburn Road	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS	Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).; Geometric Least Squares means are provided.	3 days
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS	Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).; Geometric Least Squares means are provided.	3 days