N/A
N=160
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01970995 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) — 83.21; 617.04; 83.57 pg/mg creat — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- THS 2.2 Menthol (mTHS 2.2) (Other); Smoking Abstinence (SA) (Other); Menthol Conventional Cigarette (mCC) (Other)
- Age
- Adult, Older Adult · 23+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) |
83.21; 617.04; 83.57 | <.001 sig |
| PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) |
304.56; 601.11; 183.61 | <.001 sig |
| PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA) |
119.18; 1086.89; 104.83 | <.001 sig |
| PRIMARY Levels of Carboxyhemoglobin (COHb) |
2.47; 5.49; 2.49 | <.001 sig |
| PRIMARY Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL) |
22.48; 96.65; 14.90 | <.001 sig |
Summary
The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.
Eligibility Criteria
Inclusion Criteria
- Subject is Japanese.
- Smoking, 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 in the next 3 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 cytochrome P450 1 A2 (CYP1A2) or cytochrome P450 2 A6 (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 (NCT01970995). 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.