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Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

Sponsored by Philip Morris Products S.A.

About this trial

Last updated 5 years ago

Study ID

ZRHR-REXC-04-JP

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
23 to 65 Years
All
All

Trial Timing

Ended 11 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status