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Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Smoking
Interventions Other: CHTP 1.1 M
Other: mCC
Enrollment 56
Recruitment Details

Study initiated (first subject screened): 08 May 2015

On Day -3 (admission), after all inclusion/exclusion criteria were checked, all eligible subjects were enrolled and tried CHTP 1.1 M.

From enrollment, they were asked to remain abstinent from smoking for at least 24 hours before being randomized on Day 1 into 1 of the 2 sequences.

Pre-assignment Details

Number of subjects enrolled = 56, but only 48 were randomized as described below:

  • Sequence "CHTP 1.1 M then mCC": 24 subjects
  • Sequence "mCC then CHTP 1.1 M": 24 subjects

Number of subjects enrolled but NOT randomized = 8

Arm/Group Title CHTP 1.1 M Then mCC mCC Then CHTP 1.1 M
Hide Arm/Group Description

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).

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).
Period Title: Washout Period of 1 Day (Day -1)
Started 24 24
Completed 24 24
Not Completed 0 0
Period Title: First Intervention (Day 1)
Started 24 24
Completed 24 24
Not Completed 0 0
Period Title: Washout Period of 1 Day (Day 2)
Started 24 24
Completed 24 24
Not Completed 0 0
Period Title: Second Intervention (Day 3)
Started 24 24
Completed 24 24
Not Completed 0 0
Arm/Group Title CHTP 1.1 M Then mCC mCC Then CHTP 1.1 M Total
Hide Arm/Group Description

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).

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).
Total of all reporting groups
Overall Number of Baseline Participants 23 24 47
Hide Baseline Analysis Population Description
The overall PK population consisted of 47 subjects. 1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC" ) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 24 participants 47 participants
44.7  (10.03) 40.7  (11.48) 42.6  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 47 participants
Female
11
  47.8%
14
  58.3%
25
  53.2%
Male
12
  52.2%
10
  41.7%
22
  46.8%
International Organization for Standardization (ISO) nicotine Yield  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 47 participants
≤ 0.6 mg
11
  47.8%
11
  45.8%
22
  46.8%
> 0.6 to ≤ 1 mg
12
  52.2%
13
  54.2%
25
  53.2%
1.Primary Outcome
Title Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC
Hide Description

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.

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.
Hide Outcome Measure Data
Hide Analysis Population Description

The PK population consisted of 47 subjects.

1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC") due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC.

Arm/Group Title CHTP 1.1 M Menthol Cigarette (mCC)
Hide Arm/Group Description:
The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
Overall Number of Participants Analyzed 47 47
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ng/mL
6.2950
(5.2610 to 7.5322)
9.8463
(8.2290 to 11.7815)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.1 M, Menthol Cigarette (mCC)
Comments The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 63.9326
Confidence Interval (2-Sided) 95%
49.6045 to 82.3991
Estimation Comments

Geometric LS mean ratio (CHTP 1.1 M:mCC).

Expressed as %

2.Primary Outcome
Title 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
Hide Description

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.

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.
Hide Outcome Measure Data
Hide Analysis Population Description

The PK population consisted of 47 subjects.

1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC") due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC.

Arm/Group Title CHTP 1.1 M Menthol Cigarette (mCC)
Hide Arm/Group Description:
The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
Overall Number of Participants Analyzed 47 47
Least Squares Mean (95% Confidence Interval)
Unit of Measure: h*ng/mL
8.5311
(6.9550 to 10.4642)
14.2172
(11.5908 to 17.4388)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CHTP 1.1 M, Menthol Cigarette (mCC)
Comments The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.
Method of Estimation Estimation Parameter Geometric LS Mean Ratio
Estimated Value 60.0052
Confidence Interval (2-Sided) 95%
44.9517 to 80.0997
Estimation Comments

Geometric LS mean ratio (CHTP 1.1 M:mCC).

Expressed as %

Time Frame From the informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
Adverse Event Reporting Description The safety was assessed in the safety population, consisting of 56 subjects: 48 randomized subjects (24 subjects in the "CHTP 1.1 M then mCC" sequence, 24 subjects in the "mCC then CHTP 1.1 M" sequence), and 8 non-randomized subjects who were exposed to CHTP 1.1 M from the product test on Admission.
 
Arm/Group Title CHTP 1.1 M Then mCC mCC Then CHTP 1.1 M Enrolled But Not Randomized
Hide Arm/Group Description

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).

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).
Subjects who tried the CHTP 1.1 M at Admission but were not randomized in 1 of the 2 sequences as they were back-up subjects
All-Cause Mortality
CHTP 1.1 M Then mCC mCC Then CHTP 1.1 M Enrolled But Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CHTP 1.1 M Then mCC mCC Then CHTP 1.1 M Enrolled But Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CHTP 1.1 M Then mCC mCC Then CHTP 1.1 M Enrolled But Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.

The Intellectual Property rights and research results from the present study belong to the Sponsor.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steffen Fredersdorf
Organization: Philip Morris Products S.A.
Phone: +41 (58) 242 2182
EMail: Steffen.Fredersdorf@pmi.com
Layout table for additonal information
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02466412    
Other Study ID Numbers: P2M-PK-04-JP
P2M-PK-04-JP ( Other Identifier: Philip Morris Products S.A. )
First Submitted: May 7, 2015
First Posted: June 9, 2015
Results First Submitted: February 17, 2017
Results First Posted: April 11, 2017
Last Update Posted: May 13, 2020