Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

• ClinicalTrials.gov Identifier: NCT02466412
• Recruitment Status: Completed
• First Posted: June 9, 2015
• Results First Posted: April 11, 2017
• Last Update Posted: May 13, 2020
• Sponsor: Philip Morris Products S.A.
• Information provided by (Responsible Party): Philip Morris Products S.A.

Tracking Information

• First Submitted Date: May 7, 2015
• First Posted Date: June 9, 2015
• Results First Submitted Date: February 17, 2017
• Results First Posted Date: April 11, 2017
• Last Update Posted Date: May 13, 2020
• Study Start Date: May 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2017)

• Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC [ Time Frame: Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0. ]
  T0 = start of single product use. Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares (LS) means are provided.
• Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC [ Time Frame: Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0. ]
  T0 = start of single product use. Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares means are provided.

Original Primary Outcome Measures (submitted: June 8, 2015)

• Ratio of the maximum concentration (Cmax) of nicotine following single use of CHTP 1.1 M and mCC [ Time Frame: Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use) ]
• Ratio of the area under the plasma concentration versus time curve from time zero (pre-product use) to last time point [AUC(0-last)] following single use of CHTP 1.1 M and mCC [ Time Frame: Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use) ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nicotine Pharmacokinetic Profile of the CHTP 1.1 M
• Official Title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes
• Brief Summary: The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Smoking

Intervention

• Other: CHTP 1.1 M
  Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)
• Other: mCC
  Single use of subject's own menthol conventional cigarette (mCC)

Study Arms

• Active Comparator: CHTP 1.1 M then mCC

  Each subject will follow the below study design:

  • Day -1 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of CHTP 1.1 M)
  • Day 2 = Wash-out
  • Day 3 = 2nd intervention (single product use of mCC).
  Interventions:

  • Other: CHTP 1.1 M
  • Other: mCC
• Active Comparator: mCC then CHTP 1.1 M

  Each subject will follow the below study design:

  • Day -1 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mCC)
  • Day 2 = Wash-out
  • Day 3 = 2nd intervention (single product use of CHTP 1.1 M).
  Interventions:

  • Other: CHTP 1.1 M
  • Other: mCC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2017): 56
• Original Estimated Enrollment (submitted: June 8, 2015): 48
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject is Japanese.
• Subject is at a minimum 23 years of age.
• Smoking, healthy subject as judged by the Investigator.
• Subject has smoked for at least the last 3 years
• Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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 a drug (whichever is longer) which has an impact on CYP2A6 activity.
• Female subject is pregnant or breast feeding.
• Female subject does not agree to use an acceptable method of effective contraception.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT02466412
• Other Study ID Numbers: P2M-PK-04-JP; P2M-PK-04-JP ( Other Identifier: Philip Morris Products S.A. )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Philip Morris Products S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Philip Morris Products S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Christelle Haziza, PhD; Philip Morris Products S.A.
• Principal Investigator: Fumimasa Nobuoka, MD; Ageo Medical Clinic

• PRS Account: Philip Morris Products S.A.
• Verification Date: May 2020