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

Launched by PHILIP MORRIS PRODUCTS S.A. · Oct 9, 2013

Keywords

ClinConnect Summary

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Gender

ALL

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.