NCT01970982

Brief Summary

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 17, 2016

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

October 18, 2013

Results QC Date

January 26, 2016

Last Update Submit

March 3, 2020

Conditions

Smoking

Keywords

Candidate modified risk tobacco productConventional cigaretteReduced exposureHPHCsConfinement

Outcome Measures

Primary Outcomes (4)

  • Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

    Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares LS) means are provided as descriptive statistics.

    5 days

  • Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

    Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

    5 days

  • Concentration of S-phenylmercapturic Acid (S-PMA)

    Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

    5 days

  • Levels of Carboxyhemoglobin (COHb)

    % COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.

    5 days

Study Arms (3)

Tobacco Heating System (THS 2.2)

EXPERIMENTAL

Ad libitum use of THS 2.2 for 5 days in confinement

Other: Tobacco Heating System (THS 2.2)

Smoking abstinence (SA)

SHAM COMPARATOR

Abstinence from smoking for 5 days in confinement

Other: Smoking abstinence (SA)

Conventional cigarette (CC)

ACTIVE COMPARATOR

Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement

Other: Conventional cigarette (CC)

Interventions

Tobacco Heating System (THS 2.2)OTHER

THS 2.2 ad libitum for 5 days in confinement

Tobacco Heating System (THS 2.2)
Smoking abstinence (SA)OTHER

SA for 5 days in confinement

Smoking abstinence (SA)
Conventional cigarette (CC)OTHER

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Conventional cigarette (CC)

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
  • 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).
  • The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
  • For women: Subject is pregnant or is breast feeding.
  • For women: Subject does not agree to use an acceptable method of effective contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku

Tokyo, Japan

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

  • Takuya Kunito, MD

    Higashi Shinjuku 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 28, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

March 12, 2020

Results First Posted

October 17, 2016

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)