N/A
N=160
Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01970982 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) — 106.25; 460.15; 91.73 pg/mg creat — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tobacco Heating System (THS 2.2) (Other); Smoking abstinence (SA) (Other); Conventional cigarette (CC) (Other)
- Age
- Adult, Older Adult · 23+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) |
106.25; 460.15; 91.73 | <0.001 sig |
| PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) |
311.68; 589.65; 204.23 | <0.001 sig |
| PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA) |
142.05; 905.89; 122.02 | <0.001 sig |
| PRIMARY Levels of Carboxyhemoglobin (COHb) |
2.41; 5.13; 2.37 | <0.001 sig |
Summary
The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
Eligibility Criteria
Inclusion Criteria
- Subject is Japanese.
- Smoking, healthy subject as judged by the Investigator.
- Subject smokes at least 10 commercially available non-menthol CCs 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 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 (NCT01970982). 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.