Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT02643693
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
User Acceptability of a Nicotine Lactate Delivery System (P3L)
Sponsor:
Philip Morris Products S.A.
Organization:
Study Overview
Official Title:
User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with their own brand of CC or the VUSE e-cigarette system.
Detailed Description:
The total duration of the study for an individual subject will be between 3 and 8 weeks, including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the preference evaluation session (subjects will be given the choice of using ad libitum the P3L or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive safety follow-up period.
The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.
The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: