NCT01780688

Brief Summary

The main goal of this exploratory study is to evaluate the pharmacokinetic profile of nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional cigarettes (CC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

January 15, 2013

Last Update Submit

November 18, 2019

Conditions

Smoking

Keywords

Modified risk tobacco product (MRTP)SmokingNicotine profile

Outcome Measures

Primary Outcomes (2)

  • Nicotine Cmax

    Maximum plasma concentration (Cmax)

    Single use (1 day)

  • Nicotine AUC

    Nicotine plasma concentration, area under the curve (AUCt)

    Single use (1 day)

Secondary Outcomes (6)

  • Nicotine concentrations

    Single use (1 day); multiple use (1 day)

  • Questionnaire of smoking urges (brief version) (QSU-brief)

    single use (1 day); multiple use (1 day)

  • Safety monitoring

    7 days + 7 days follow-up

  • Nicotine tmax

    Single use (1 day)

  • Cough Visual Analog Scale

    7 days

  • +1 more secondary outcomes

Study Arms (2)

smoking conventional cigarettes (CC)

ACTIVE COMPARATOR

After a 1-day nicotine deprivation, subjects are smoking one single cigarette (usual own brand) on one day and then smoking ad libitum on the subsequent day

Other: Conventional cigarettes (CC)Other: THS 2.1

using the Tobacco Heating System 2.1 (THS 2.1)

EXPERIMENTAL

After a 1-day nicotine deprivation, subjects are puffing one single tobacco stick using the THS 2.1 on one day and then puffing ad libitum on the subsequent day

Other: Conventional cigarettes (CC)Other: THS 2.1

Interventions

Conventional cigarettes (CC)OTHER

Subjects are randomized in a 1:1 fashion to be assigned to one of the 2 sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC.

smoking conventional cigarettes (CC)using the Tobacco Heating System 2.1 (THS 2.1)
THS 2.1OTHER

Subjects are randomized in a 1:1 fashion to be assigned in one of the sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC

smoking conventional cigarettes (CC)using the Tobacco Heating System 2.1 (THS 2.1)

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has signed an informed consent form before commencement of study procedures
  • Healthy Caucasian aged between 23 to 65 years
  • Subject is current smoker for at least 3 years (based on self-reporting and biochemically verified), who, for the last 4 weeks, had smoked at least 10 commercially available non-mentholated CC per day, and is not planning to make a quit attempt within the next 3 months

You may not qualify if:

  • As per Investigator judgment, the subject should not participate in the study for any reason (e.g. medical, psychiatric and/or social reason)
  • The subject has a medical condition requiring smoking cessation, or has a clinically relevant disease / condition which could interfere with the study participation and/or study results
  • The subject has participated in a clinical study within 3 months prior to the Screening Visit
  • Pregnant or lactating woman, and for woman of childbearing potential, absence / refusal to use an acceptable method of effective contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion, 22-24 Lisburn Road

Belfast, BT9 AD6, United Kingdom

Location

Related Publications (1)

  • Picavet P, Haziza C, Lama N, Weitkunat R, Ludicke F. Comparison of the Pharmacokinetics of Nicotine Following Single and Ad Libitum Use of a Tobacco Heating System or Combustible Cigarettes. Nicotine Tob Res. 2016 May;18(5):557-63. doi: 10.1093/ntr/ntv220. Epub 2015 Oct 5.

    PMID: 26438645RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Adrian J Stewart, MD

    Celerion, Belfast, Northern Ireland

    PRINCIPAL INVESTIGATOR

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

January 15, 2013

First Posted

January 31, 2013

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations

GB(1)