N/A
N=160
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01989156 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Concentration of Monohydroxybutenylmercapturic Acid (MHBMA) — 110.96; 882.25; 94.97 pg/mg creat — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- THS 2.2 Menthol (mTHS 2.2) (Other); Menthol Conventional Cigarette (mCC) (Other); Smoking Abstinence (SA) (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Monohydroxybutenylmercapturic Acid (MHBMA) |
110.96; 882.25; 94.97 | <0.001 sig |
| PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) |
278.13; 607.68; 152.05 | <0.001 sig |
| PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA) |
134.11; 1065.91; 131.05 | <0.001 sig |
| PRIMARY Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL) |
41.05; 155.45; 54.03 | <0.001 sig |
| PRIMARY Levels of Carboxyhemoglobin (COHb) |
2.33; 6.11; 2.39 | <0.001 sig |
Summary
Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).
Eligibility Criteria
Inclusion Criteria
- Smoking, apparently healthy subject as judged by the Investigator.
- Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.
- Subject has smoked for at least the last 3 consecutive years.
- Subject does not plan to quit smoking within the next 6 months.
Exclusion Criteria
- As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
- The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
- For women: Subject is pregnant or is breast feeding.
- For women: Subject does not agree to use an acceptable method of effective contraception.
Data sourced from ClinicalTrials.gov (NCT01989156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.