Nicotine Pharmacokinetics From Research Electronic Nicotine Delivery System S-TA-U001 in Smokers and E-Cigarette Users
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
To better understand the PK and associated pharmacodynamic (PD) responses produced by the
Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to
- The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved
smoking cessation product, the NICORETTE Inhalator, in current non-menthol cigarette
smokers who have some limited e-cigarette experience (Group 1).
- Commercially available products in current primarily e-cigarette users (experienced ENDS
users) (Group 2) The PK/PD session for each product will be conducted in a controlled
clinical setting with frequent PK sampling after 14 hours of supervised abstinence from
all forms of nicotine. Subjects will familiarize themselves with the Research ENDS
S-TA-U001 and NICORETTE Inhalator by using each product in the real world for one day
before the PK/PD session for that product.
Primary Objectives:
Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma
concentration [Cmax], time to maximum plasma concentration [Tmax], area under the
concentration-time curve [AUC], and terminal half-life [t1/2]) for 10 inhalation and ad lib
sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level
during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK
profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured at
the baseline session, and to demonstrate superiority of PK profile of Research ENDS S-TA-U001
to that of the marketed NICORETTE Inhalator.
Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001 and
explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and 6
hour ad lib use sessions, and to compare the PK profile between Research ENDS S-TA-U001 to
the profile of a commercial ENDS product measured at the baseline session.
Secondary objectives:
Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to
the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS
for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to evaluate
the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a combustion
cigarette or the NICORETTE Inhalator (Group 1) or a commercial ENDS product (Group 2), and to
evaluate various biomarkers following use of each test product.
Phase:
Phase 1
Details
Lead Sponsor:
NJOY, Inc.
Collaborators:
LA Clinical Trials National Institute on Drug Abuse (NIDA)