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

NCT01959607 | Completed Results

• 1 other identifier: ZRHR-PK-02-JP
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.

Conditions

Smoking

Keywords

Smoking; Nicotine absorption; Candidate modified risk tobacco product; Cigarettes; Nicotine Replacement Therapy gum (NRT gum)

Outcome Measures

Primary Outcomes (2)

• Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT

  T0 = start of single product use. 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.

  Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0

• 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 NRT

  T0 = start of single product use. 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.

  Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0

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 NRT

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 NRT gum \[Nicorette® 2mg\]).

Other: THS 2.2; Other: NRT Gum

NRT 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 NRT gum \[Nicorette® 2mg\]) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of THS 2.2).

Other: THS 2.2; Other: NRT Gum

Interventions

THS 2.2 OTHER

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

CC then THS 2.2; NRT then THS 2.2; THS 2.2 then CC; THS 2.2 then NRT

CC OTHER

Single use of subject's own cigarette (CC)

CC then THS 2.2; THS 2.2 then CC

NRT Gum OTHER

Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

NRT then THS 2.2; THS 2.2 then NRT

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is Japanese.
• Smoking, healthy subject as judged by the Investigator.
• Subject smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks.
• 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)

Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi

Tokyo, 184-0005, Japan

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle Haziza
• Organization: Philip Morris Products S.A.

clinicaltrials.pmi@pmi.com

+41 58 242 11 11

Study Officials

• Masayuki Sugimoto, MD PhD

  Koganeibashi Sakura Clinic

  PRINCIPAL INVESTIGATOR

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

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 8, 2013
• First Posted: October 10, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 16, 2025
• Results First Posted: July 28, 2015

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)