Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

Launched by PHILIP MORRIS PRODUCTS S.A. · Dec 23, 2015

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is aged ≥ 28 years.
• • Subject is Caucasian.
• • Subject is healthy, as judged by the Investigator.
• • Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
• • Subject has smoked at least for the last 10 years.
• • Subject does not plan to quit smoking in the next 6 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.