SmokingNCT01967719

Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)

A study testing mTHS 2.2, mCC and NNS in people with Smoking, run by Philip Morris Products S.A. at 1 site in United States.

Completed

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

Official record

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Trial summary

The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS). Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: mTHS 2.2, mCC and NNS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Oct 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 22 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is aged from 22 to 65 years (inclusive).
Smoking, healthy subject as judged by the Investigator.
Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
Subject has smoked for at least the last 3 consecutive years.

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.

United States1 site

Central Kentucky Research Associates
Lexington, Kentucky, 40509

Other trials in United States

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 Nasal Spray

Conditions: Smoking
Being tested: mTHS 2.2, mCC, NNS
Keywords: Smoking, Nicotine absorption, Candidate modified risk tobacco product, Conventional cigarette, Nicotine replacement therapy: nasal spray
Medical subject headings: Smoking

What participants receive

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

mTHS 2.2Other
Single use of mTHS 2.2
mCCOther
Single use of subject's own mCC
NNSOther
Single administration of 1 mg of nicotine

Study groups in NCT01967719
Study group	Role	What they receive
mTHS 2.2 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 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC). Receives: Other: mTHS 2.2; Other: mCC
mCC then mTHS 2.2	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 2.2). Receives: Other: mTHS 2.2; Other: mCC
mTHS 2.2 then NNS	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 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS) Receives: Other: mTHS 2.2; Other: NNS
NNS then mTHS 2.2	Active comparator	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NNS) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS 2.2). Receives: Other: mTHS 2.2; Other: NNS

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 2.2, mCC and NNS
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 (geometric LS) means are provided.
Measured: 3 days
Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS
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: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013May 2014

First posted23 Oct 2013 (estimated)
Study startOct 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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01967719
Sponsor's protocol ID: ZRHM-PK-06-US
Other IDs: ZRHM-PK-06-US
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

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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All Smoking trials

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 Nasal Spray
ClinicalTrials.gov ID: NCT01967719
Acronym / sponsor ID: ZRHM-PK-06-US
Conditions: Smoking
Keywords: Smoking, Nicotine absorption, Candidate modified risk tobacco product, Conventional cigarette, Nicotine replacement therapy: nasal spray
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Nov 2013 (actual)
Study completion: May 2014 (actual)
First posted: 23 Oct 2013 (estimated)
Results: Posted 7 Feb 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: 4

Arm	Type	Receives
mTHS 2.2 then mCC	Active comparator	Other: mTHS 2.2, Other: mCCEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).
mCC then mTHS 2.2	Active comparator	Other: mTHS 2.2, 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 2.2).
mTHS 2.2 then NNS	Active comparator	Other: mTHS 2.2, Other: NNSEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS)
NNS then mTHS 2.2	Active comparator	Other: mTHS 2.2, Other: NNSEach subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NNS) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS 2.2).

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is aged from 22 to 65 years (inclusive).
Smoking, healthy subject as judged by the Investigator.
Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
Subject has smoked for at least the last 3 consecutive years.

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
mTHS 2.2Single use of mTHS 2.2	Other	NNS then mTHS 2.2, mCC then mTHS 2.2, mTHS 2.2 then NNS, mTHS 2.2 then mCC
mCCSingle use of subject's own mCC	Other	mCC then mTHS 2.2, mTHS 2.2 then mCC
NNSSingle administration of 1 mg of nicotine	Other	NNS then mTHS 2.2, mTHS 2.2 then NNS

Primary outcome

Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS
Time frame: 3 days
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 (geometric LS) means are provided.
Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS
Time frame: 3 days
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 7 Feb 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
mTHS 2.2 Then mCC	22	22
mCC Then mTHS 2.2	22	22
mTHS 2.2 Then NNS	9	9
NNS Then mTHS 2.2	9	9

Primary outcome: Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS

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

Measure	mTHS 2.2 - Group 1 n = 41	mCC - Group 1 n = 41	mTHS 2.2 - Group 2 n = 17	NNS - Group 2 n = 17
Value	7.40 (6.21 to 8.82)	13.08 (10.99 to 15.58)	8.40 (6.17 to 11.43)	3.23 (2.37 to 4.40)

mTHS 2.2 - Group 1 vs mCC - Group 1: Geometric LS Mean Ratio: 56.57 (95% CI 44.21 to 72.39), ANOVA

Population analysed: Pharmacokinetics (PK) populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.

Primary outcome: Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS

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

Measure	mTHS 2.2 - Group 1 n = 41	mCC - Group 1 n = 41	mTHS 2.2 - Group 2 n = 17	NNS - Group 2 n = 17
Value	16.53 (13.84 to 19.74)	29.71 (24.88 to 35.47)	15.59 (10.80 to 22.49)	8.72 (6.04 to 12.58)

mTHS 2.2 - Group 1 vs mCC - Group 1: Geometric LS Mean Ratio: 55.64 (95% CI 43.30 to 71.50), ANOVA

Population analysed: PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.

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
Group 1	0 of 44 (0%)	12 of 44 (27.3%)	Not reported
Group 2	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Enrolled But Not Randomized	0 of 2 (0%)	0 of 2 (0%)	Not reported

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.

James L Borders, MD principal investigator

Central Kentucky Research Associates

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 2.2, mCC and NNS in people with Smoking, run by Philip Morris Products S.A. at 1 site in United States.

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 4 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 United States. 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 7 Feb 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 mTHS 2.2, mCC and NNS (time frame: 3 days). 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 NCT01967719.

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.