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

NCT01967732 | Completed Results

• 2 other identifiers: ZRHR-PK-01-EU2013-003097-27
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Smoking

Keywords

Smoking; Nicotine absorption; Modified risk tobacco product; Conventional cigarette; Nicotine replacement therapy; Nicotine nasal spray

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

THS 2.2 then CC

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of THS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of CC).

Other: THS 2.2; Other: CC

CC then THS 2.2

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of CC) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of THS 2.2).

Other: THS 2.2; Other: CC

THS 2.2 then NNS

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of THS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS)

Other: THS 2.2; Other: NNS

NNS then THS 2.2

ACTIVE COMPARATOR

Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NNS) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of THS 2.2).

Other: THS 2.2; Other: NNS

Interventions

THS 2.2 OTHER

Single use of the Tobacco Heating System 2.2 (THS 2.2)

CC then THS 2.2; NNS then THS 2.2; THS 2.2 then CC; THS 2.2 then NNS

CC OTHER

Single use of subject's own conventional cigarette (CC)

CC then THS 2.2; THS 2.2 then CC

NNS OTHER

Single administration of 1 mg of nicotine

NNS then THS 2.2; THS 2.2 then NNS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Celerion GB Ltd, 22-24 Lisburn Road

Belfast, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle HAZIZA, PhD
• Organization: Philip Morris Products S.A.

Christelle.Haziza@pmi.com

+41 (58) 242 2625

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

• Adrian Johnston Stewart, MD

  Celerion GB Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: March 17, 2020
• Results First Posted: August 15, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)