An interventional study of mTHS and mCC in Smoking, sponsored by Philip Morris Products S.A.. Completed at 1 site in Japan. Open to participants aged 23 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Philip Morris Products S.A. · Not applicable, Interventional, and Other
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).
Philip Morris Products S.A. is the lead sponsor of 46 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: mTHS · Other: mCC
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).
Other: mTHS · Other: mCC
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)
Other: mTHS · Other: NRT
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).
Other: mTHS · Other: NRT
Single use of Tobacco Heating System 2.2 Menthol (mTHS)
Single use of subject's own menthol cigarette (mCC)
Single administration of 2 mg gum (Nicorette® 2mg)
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.
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
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.
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
Study initiated (first subject screened): 01 August 2013 At admission (Day -1), all the subjects performed a product trial (Tobacco Sticks and subsequently NRT gum). From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences.
| Milestone | mTHS Then mCC | mCC Then mTHS | mTHS Then NRT | NRT Then mTHS |
|---|---|---|---|---|
| Started | 22 | 22 | 9 | 9 |
| Completed | 22 | 22 | 9 | 9 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | mTHS Then mCC | mCC Then mTHS | mTHS Then NRT | NRT Then mTHS |
|---|---|---|---|---|
| Started | 22 | 22 | 9 | 9 |
| Completed | 21 | 22 | 9 | 9 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
| Milestone | mTHS Then mCC | mCC Then mTHS | mTHS Then NRT | NRT Then mTHS |
|---|---|---|---|---|
| Started | 21 | 22 | 9 | 9 |
| Completed | 21 | 22 | 9 | 9 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | mTHS Then mCC | mCC Then mTHS | mTHS Then NRT | NRT Then mTHS |
|---|---|---|---|---|
| Started | 21 | 22 | 9 | 9 |
| Completed | 21 | 22 | 9 | 9 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| ng/mL | mTHS - Group 1 | mCC - Group 1 | mTHS - Group 2 | NRT - Group 2 |
|---|---|---|---|---|
| Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT | 10.70 (8.94 to 12.80) | 12.09 (10.10 to 14.47) | 7.64 (5.39 to 10.81) | 7.52 (5.31 to 10.64) |
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.
| ng*h/mL | mTHS - Group 1 | mCC - Group 1 | mTHS - Group 2 | NRT - Group 2 |
|---|---|---|---|---|
| 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 | 23.99 (20.87 to 27.57) | 24.45 (21.27 to 28.10) | 15.61 (11.96 to 20.37) | 27.94 (21.41 to 36.45) |
Collected over From informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/44 (0%) | 0/44 (0%) |
| Group 2 | — | 0/18 (0%) | 1/18 (5.6%) |
| Enrolled But Not Randomized | — | 0/11 (0%) | 0/11 (0%) |
| Event | Group 1 | Group 2 | Enrolled But Not Randomized |
|---|---|---|---|
| Hemoglobin decreasedInvestigations | 0/44 | 1/18 | 0/11 |
PK population: all randomized subjects who completed at least 1 of the single-use days, with at least 1 derived PK parameter. Subjects with major protocol deviations impacting the evaluation of the results were excluded. 62 randomized subjects : 44 in Group 1, 18 in Group 2. 61 completers: 43 in Group 1 (1 withdrawn subject), 18 in Group 2.
| Age, Customized(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Between 23 and 65 years | 33.4 ± 10.03 | 30.7 ± 7.80 | 32.6 ± 9.44 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 20 | 9 | 29 |
| Male | 23 | 9 | 32 |
| International Organization for Standardization (ISO) nicotine level(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| ≤ 0.6 mg | 25 | 10 | 35 |
| > 0.6 to ≤ 1 mg | 18 | 8 | 26 |
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Philip Morris Products S.A.