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

• ClinicalTrials.gov Identifier: NCT01970982
• Recruitment Status: Completed
• First Posted: October 28, 2013
• Results First Posted: October 17, 2016
• Last Update Posted: March 12, 2020
• Sponsor: Philip Morris Products S.A.
• Information provided by (Responsible Party): Philip Morris Products S.A.

Tracking Information

• First Submitted Date: October 18, 2013
• First Posted Date: October 28, 2013
• Results First Submitted Date: January 26, 2016
• Results First Posted Date: October 17, 2016
• Last Update Posted Date: March 12, 2020
• Study Start Date: July 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2016)

• Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) [ Time Frame: 5 days ]
  Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares LS) means are provided as descriptive statistics.
• Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) [ Time Frame: 5 days ]
  Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
• Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 5 days ]
  Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
• Levels of Carboxyhemoglobin (COHb) [ Time Frame: 5 days ]
  % 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.

Original Primary Outcome Measures (submitted: October 26, 2013)

To demonstrate reduced levels of monohydroxybutenyl mercapturic acid (MHBMA); 3-hydroxypropylmercapturic acid (3-HPMA); S-phenylmercapturic acid (S-PMA) expressed as concentration adjusted to creatinine in urine and carboxyhemoglobin (COHb) in blood. [ Time Frame: 5 days ]

To demonstrate the reduction of exposure to respectively 1,3-butadiene; acrolein; benzene and carbon monoxide (HPHCs) after 5 days of switching from conventional cigarettes to THS 2.2 as compared to conventional cigarettes.

• 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: Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting
• Official Title: A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement
• Brief 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 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Smoking

Intervention

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

Study Arms

• Experimental: Tobacco Heating System (THS 2.2)
  Ad libitum use of THS 2.2 for 5 days in confinement
  Intervention: Other: Tobacco Heating System (THS 2.2)
• Sham Comparator: Smoking abstinence (SA)
  Abstinence from smoking for 5 days in confinement
  Intervention: Other: Smoking abstinence (SA)
• Active Comparator: Conventional cigarette (CC)
  Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
  Intervention: Other: Conventional cigarette (CC)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 19, 2014): 166
• Original Estimated Enrollment (submitted: October 26, 2013): 320
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Years to 65 Years (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: NCT01970982
• Other Study ID Numbers: ZRHR-REXC-04-JP; ZRHR-REXC-04-JP ( Other Identifier: Philip Morris Products S.A. )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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

• Principal Investigator: Takuya Kunito, MD; Higashi Shinjuku Clinic
• Study Chair: Christelle Haziza, PhD; Philip Morris Products S.A.

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