SmokingNCT01967706
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
A study testing mTHS, mCC and NRT in people with Smoking, run by Philip Morris Products S.A. at 1 site in Japan.
Trial 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 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a… Read more about this study
- Who is it for?
- Ages 23 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- mTHS, mCC and NRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is Japanese.
- Smoking, healthy subject as judged by the Investigator.
- Subject has smoked at least 10 commercially available mCCs 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.
Who cannot join
- 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 medication (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.
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 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).
- Conditions
- Smoking
- Being tested
- mTHS, mCC, NRT
- Keywords
- Smoking, Nicotine absorption, Candidate modified risk tobacco product, Cigarette, Nicotine replacement therapy, Nicotine gum
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTHSOther
Single use of Tobacco Heating System 2.2 Menthol (mTHS)
mCCOther
Single use of subject's own menthol cigarette (mCC)
NRTOther
Single administration of 2 mg gum (Nicorette® 2mg)
| Study group | Role | What they receive |
|---|---|---|
| mTHS then mCC | Active comparator | Each subject will follow the below study design:
* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of mTHS)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mCC). Receives: Other: mTHS; Other: mCC |
| mCC then mTHS | Active comparator | Each subject will follow the below study design:
* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of mCC)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mTHS). Receives: Other: mTHS; Other: mCC |
| mTHS 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 mTHS)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single administration of NRT) Receives: Other: mTHS; Other: NRT |
| NRT then mTHS | Active comparator | Each subject will follow the below study design:
* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single administration of NRT)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mTHS). Receives: Other: mTHS; Other: NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC 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.
Measured: 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 mTHS, mCC 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christelle Haziza, PhD, Study chair, Philip Morris Products S.A.Fumimasa Nobuoka, MD, Principal investigator, Ageo Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967706
- Sponsor's protocol ID
- ZRHM-PK-05-JP
- Other IDs
- ZRHM-PK-05-JP
- Status last verified
- Mar 2020
- First submitted
- 18 Oct 2013
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.
- ClinicalTrials.gov ID
- NCT01967706
- Acronym / sponsor ID
- ZRHM-PK-05-JP
- Conditions
- Smoking
- Keywords
- Smoking, Nicotine absorption, Candidate modified risk tobacco product, Cigarette, Nicotine replacement therapy, Nicotine gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 2 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mTHS then mCC | Active comparator | Other: mTHS, Other: mCCEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC). |
| mCC then mTHS | Active comparator | Other: mTHS, Other: mCCEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mCC) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS). |
| mTHS then NRT | Active comparator | Other: mTHS, Other: NRTEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NRT) |
| NRT then mTHS | Active comparator | Other: mTHS, Other: NRTEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NRT) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS). |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is Japanese.
- Smoking, healthy subject as judged by the Investigator.
- Subject has smoked at least 10 commercially available mCCs 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.
Key exclusion criteria (4 listed)
- 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 medication (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mTHSSingle use of Tobacco Heating System 2.2 Menthol (mTHS) | Other | NRT then mTHS, mCC then mTHS, mTHS then NRT, mTHS then mCC |
| mCCSingle use of subject's own menthol cigarette (mCC) | Other | mCC then mTHS, mTHS then mCC |
| NRTSingle administration of 2 mg gum (Nicorette® 2mg) | Other | NRT then mTHS, mTHS then NRT |
Primary outcome
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT
Time frame: 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
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.
Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT
Time frame: 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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Haziza, PhD study chair
Philip Morris Products S.A.
Fumimasa Nobuoka, MD principal investigator
Ageo Medical Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mTHS, mCC and NRT in people with Smoking, run by Philip Morris Products S.A. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.