Trial Outcomes & Findings for Nicotine Pharmacokinetic Profile of the CHTP 1.1 M (NCT NCT02466412)
NCT ID: NCT02466412
Last Updated: 2020-05-13
Results Overview
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.
COMPLETED
NA
56 participants
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.
2020-05-13
Participant Flow
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.
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
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Washout Period of 1 Day (Day -1)
STARTED
|
24
|
24
|
|
Washout Period of 1 Day (Day -1)
COMPLETED
|
24
|
24
|
|
Washout Period of 1 Day (Day -1)
NOT COMPLETED
|
0
|
0
|
|
First Intervention (Day 1)
STARTED
|
24
|
24
|
|
First Intervention (Day 1)
COMPLETED
|
24
|
24
|
|
First Intervention (Day 1)
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 1 Day (Day 2)
STARTED
|
24
|
24
|
|
Washout Period of 1 Day (Day 2)
COMPLETED
|
24
|
24
|
|
Washout Period of 1 Day (Day 2)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Day 3)
STARTED
|
24
|
24
|
|
Second Intervention (Day 3)
COMPLETED
|
24
|
24
|
|
Second Intervention (Day 3)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Pharmacokinetic Profile of the CHTP 1.1 M
Baseline characteristics by cohort
| Measure |
CHTP 1.1 M Then mCC
n=23 Participants
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).
|
mCC Then CHTP 1.1 M
n=24 Participants
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
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 10.03 • n=39 Participants
|
40.7 years
STANDARD_DEVIATION 11.48 • n=41 Participants
|
42.6 years
STANDARD_DEVIATION 10.86 • n=35 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
International Organization for Standardization (ISO) nicotine Yield
≤ 0.6 mg
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
International Organization for Standardization (ISO) nicotine Yield
> 0.6 to ≤ 1 mg
|
12 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
CHTP 1.1 M
n=47 Participants
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.
|
Menthol Cigarette (mCC)
n=47 Participants
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.
|
|---|---|---|
|
Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC
|
6.2950 ng/mL
Interval 5.261 to 7.5322
|
9.8463 ng/mL
Interval 8.229 to 11.7815
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
CHTP 1.1 M
n=47 Participants
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.
|
Menthol Cigarette (mCC)
n=47 Participants
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.
|
|---|---|---|
|
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
|
8.5311 h*ng/mL
Interval 6.955 to 10.4642
|
14.2172 h*ng/mL
Interval 11.5908 to 17.4388
|
Adverse Events
CHTP 1.1 M Then mCC
mCC Then CHTP 1.1 M
Enrolled But Not Randomized
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER