NCT02503254

Brief Summary

The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

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, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

July 17, 2015

Results QC Date

November 4, 2016

Last Update Submit

January 26, 2023

Conditions

Smoking

Keywords

SmokingModified risk tobacco productConventional cigaretteReduced exposureConfinementCarbon Heated Tobacco Product

Outcome Measures

Primary Outcomes (4)

  • Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

    Concentrations measured on 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 on 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 on 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 (2)

CHTP 1.0

EXPERIMENTAL

Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement

Other: CHTP 1.0

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

CHTP 1.0OTHER

CHTP 1.0 ad libitum for 5 days in confinement

CHTP 1.0
Conventional Cigarette (CC)OTHER

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

Conventional cigarette (CC)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is aged ≥ 21 years.
  • Subject is Caucasian.
  • Subject is healthy, as judged by the Investigator.
  • Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
  • Subject has smoked at least for the last 3 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 the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
  • Female subject is pregnant or breast feeding.
  • Female subject does not agree to use an acceptable method of effective contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioVirtus Research Site Sp. z o.o.

Kajetany, 05-830, Poland

Location

Related Publications (1)

  • Tran CT, Bosilkovska M, de La Bourdonnaye G, Blanc N, Haziza C. Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial. Sci Rep. 2020 Nov 5;10(1):19227. doi: 10.1038/s41598-020-76222-y.

    PMID: 33154508RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Cam Tuan Tran
Organization
Philip Morris Products S.A.
CamTuan.Tran@pmi.com
+41 (58) 242 2620

Study Officials

  • Christelle Haziza, PhD

    Philip Morris Products S.A.

    STUDY CHAIR

  • Katarzyna Jarus-Dziedzic, MD, PhD

    BioVirtus Research Site

    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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

January 30, 2023

Results First Posted

March 10, 2017

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)