Part Two: Pharmacokinetic Evaluation of E-Liquid Flavors of Vuse Solo Electronic Nicotine Delivery System, An Unblinded, Parallel, Randomized Study To Assess Nicotine Uptake In Smokers

This paper reports the findings of a randomized nicotine pharmacokinetic (PK) study of a closed electronic nicotine delivery system (ENDS). The study evaluated four flavor variants of Vuse Solo ENDS where subjects used their randomized investigational product (IP) for 10 minutes ad libitum and blood samples were collected for PK assessments that included maximum plasma nicotine concentration (C max ) and area under the nicotine concentration-vs-time curve up to 60 minutes (AUC nic0–60 ). Baseline-adjusted mean C max ranged from 6.53 to 8.21 ng/mL, and mean AUC nic0–60 ranged from 206.87 to 263.52 ng*min/mL for all ENDS IPs. Results for C max and AUC nic0-60 values were consistent among the ENDS IP flavor variants tested and results indicate that flavors did not affect nicotine uptake in human subjects.