SmokingNCT02466412

Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

A study testing CHTP 1.1 M and mCC in people with Smoking, run by Philip Morris Products S.A. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy… Read more about this study

Who is it for?: Ages 23 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: CHTP 1.1 M and mCC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteJapan
Study dates: May 2015to Nov 2015
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is Japanese.
Subject is at a minimum 23 years of age.
Smoking, healthy subject as judged by the Investigator.
Subject has smoked for at least the last 3 years
Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Ageo Medical Clinic
Saitama, 362-0021

Other trials in Japan

About this study

Official title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes

Conditions: Smoking
Being tested: CHTP 1.1 M, mCC
Keywords: smoking, nicotine absorption, potential modified risk tobacco product, cigarette, Carbon Heated Tobacco Product
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHTP 1.1 MOther
Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)
mCCOther
Single use of subject's own menthol conventional cigarette (mCC)

Study groups in NCT02466412
Study group	Role	What they receive
CHTP 1.1 M then mCC	Active comparator	Each subject will follow the below study design: * Day -1 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of CHTP 1.1 M) * Day 2 = Wash-out * Day 3 = 2nd intervention (single product use of mCC). Receives: Other: CHTP 1.1 M; Other: mCC
mCC then CHTP 1.1 M	Active comparator	Each subject will follow the below study design: * Day -1 = 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 CHTP 1.1 M). Receives: Other: CHTP 1.1 M; Other: mCC

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 CHTP 1.1 M and mCC
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 (LS) means are provided.
Measured: Day 3: 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 Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC
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: Day 3: 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.

May 2015Nov 2015

First posted9 Jun 2015 (estimated)
Study startMay 2015
Primary completionAug 2015
Study completionNov 2015

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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02466412
Sponsor's protocol ID: P2M-PK-04-JP
Other IDs: P2M-PK-04-JP
Status last verified: May 2020
First submitted: 7 May 2015
Last updated: 13 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 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 of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes
ClinicalTrials.gov ID: NCT02466412
Acronym / sponsor ID: P2M-PK-04-JP
Conditions: Smoking
Keywords: smoking, nicotine absorption, potential modified risk tobacco product, cigarette, Carbon Heated Tobacco Product
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Aug 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 9 Jun 2015 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CHTP 1.1 M then mCC	Active comparator	Other: CHTP 1.1 M, Other: mCCEach subject will follow the below study design: * Day -1 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of CHTP 1.1 M) * Day 2 = Wash-out * Day 3 = 2nd intervention (single product use of mCC).
mCC then CHTP 1.1 M	Active comparator	Other: CHTP 1.1 M, Other: mCCEach subject will follow the below study design: * Day -1 = 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 CHTP 1.1 M).

Who may qualify

Ages: 23 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is Japanese.
Subject is at a minimum 23 years of age.
Smoking, healthy subject as judged by the Investigator.
Subject has smoked for at least the last 3 years
Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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 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.

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
CHTP 1.1 MSingle use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)	Other	CHTP 1.1 M then mCC, mCC then CHTP 1.1 M
mCCSingle use of subject's own menthol conventional cigarette (mCC)	Other	CHTP 1.1 M then mCC, mCC then CHTP 1.1 M

Primary outcome

Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC
Time frame: Day 3: 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 (LS) means are provided.
Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC
Time frame: Day 3: 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

Results posted to the registry on 11 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHTP 1.1 M Then mCC	24	24
mCC Then CHTP 1.1 M	24	24

Primary outcome: Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC

Time frame: Day 3: 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.. Least squares mean (95% Confidence Interval). Unit: ng/mL

Measure	CHTP 1.1 M n = 47	Menthol Cigarette (mCC) n = 47
Value	6.2950 (5.2610 to 7.5322)	9.8463 (8.2290 to 11.7815)

CHTP 1.1 M vs Menthol Cigarette (mCC): Geometric LS Mean Ratio: 63.9326 (95% CI 49.6045 to 82.3991), ANOVA

Population analysed: The PK population consisted of 47 subjects. 1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC") due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC.

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC

Time frame: Day 3: 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.. Least squares mean (95% Confidence Interval). Unit: h*ng/mL

Measure	CHTP 1.1 M n = 47	Menthol Cigarette (mCC) n = 47
Value	8.5311 (6.9550 to 10.4642)	14.2172 (11.5908 to 17.4388)

CHTP 1.1 M vs Menthol Cigarette (mCC): Geometric LS Mean Ratio: 60.0052 (95% CI 44.9517 to 80.0997), ANOVA

Adverse events

Time frame: From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHTP 1.1 M Then mCC	0 of 24 (0%)	0 of 24 (0%)	Not reported
mCC Then CHTP 1.1 M	0 of 24 (0%)	0 of 24 (0%)	Not reported
Enrolled But Not Randomized	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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 CHTP 1.1 M and mCC 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 13 May 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 11 Apr 2017). 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 CHTP 1.1 M and mCC (time frame: Day 3: 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?

On the ClinicalTrials.gov record for NCT02466412.

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 13 May 2020.