N/A
N=160
Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01959932 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) — 194.05; 2314.37; 168.01 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 · 21+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) |
194.05; 2314.37; 168.01 | <0.001 sig |
| PRIMARY Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) |
398.87; 958.03; 242.56 | <0.001 sig |
| PRIMARY Concentration of S-phenylmercapturic Acid (S-PMA) |
164.51; 2748.16; 153.66 | <0.001 sig |
| PRIMARY Levels of Carboxyhemoglobin (COHb) |
1.06; 4.53; 0.98 | <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 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
Eligibility Criteria
Inclusion Criteria
- Subject is Caucasian.
- Current healthy smoker as judged by the Principal Investigator.
- Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
- 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).
- 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 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
- Female subject is pregnant or breast feeding.
- Female subject does not agree to use an acceptable method of effective contraception.
Data sourced from ClinicalTrials.gov (NCT01959932). 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.