Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

Smoking Clinical Trial

Official title:

A Randomized, Controlled, Open-label, 3-arm Parallel Group, Single-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smoking, Healthy Subjects Switching to the Tobacco Heating System 2.2 (THS 2.2) or Smoking Abstinence, Compared to Continuing to Use Conventional Cigarettes, for 5 Days in Confinement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959932
• Other study ID #: ZRHR-REXC-03-EU
• Secondary ID: ZRHR-REXC-03-EU
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2020
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• Tobacco Heating System (THS 2.2)
THS 2.2 ad libitum for 5 days in confinement
• Smoking abstinence (SA)
SA for 5 days in confinement
• Conventional cigarette (CC)
Subject's own preferred brand of CC ad libitum for 5 days in confinement

Locations

Country	Name	City	State
Poland	BioVirtus Research Site Sp. z o.o.	Kajetany

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)	Concentrations measured at Day 5 in urine, adjusted for creatinine.; Geometric Least Squares (LS) means are provided as descriptive statistics.	5 days
Primary	Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	Concentrations measured at Day 5 in urine, adjusted for creatinine.; Geometric Least Squares means are provided as descriptive statistics.	5 days
Primary	Concentration of S-phenylmercapturic Acid (S-PMA)	Concentrations measured at Day 5 in urine, adjusted for creatinine.; Geometric Least Squares means are provided as descriptive statistics.	5 days
Primary	Levels of Carboxyhemoglobin (COHb)	% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.; Geometric Least Squares means are provided as descriptive statistics.	5 days