An interventional study of Conventional cigarette and myblu 25 mg freebase in Healthy Volunteers, sponsored by Fontem Ventures BV. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Fontem Ventures BV · Not applicable, Interventional, and Other
This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.
Fontem Ventures BV is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subject's preferred brand of commercially available conventional cigarette
Other: Conventional cigarette
myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour
Other: myblu 25 mg freebase
myblu pod-system containing 16 mg nicotine salt tobacco flavour
Other: myblu 16 mg nicotine salt
myblu pod-system containing 25 mg nicotine salt tobacco flavour
Other: myblu 25 mg nicotine salt
myblu pod-system containing 40 mg nicotine salt tobacco flavour
Other: myblu 40 mg nicotine salt
blu PRO open-system containing 48 mg nicotine salt tobacco flavour
Other: blu PRO 48 mg nicotine salt
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
E-cigarette used for 10 inhalations every 30 seconds
E-cigarette used for 10 inhalations every 30 seconds
E-cigarette used for 10 inhalations every 30 seconds
E-cigarette used for 10 inhalations every 30 seconds
E-cigarette used for 10 inhalations every 30 seconds
Nicotine pharmacokinetics Cmax
Mean maximum plasma nicotine concentration (Cmax)
Time frame: 30 minutes following the start of product use (12 measurements over the period)
Nicotine pharmacokinetics Tmax
Median time to maximum plasma nicotine concentration (Tmax)
Time frame: 30 minutes following the start of product use (12 measurements over the period)
Nicotine pharmacokinetics AUC0-30
Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)
Time frame: 30 minutes following the start of product use (12 measurements over the period)
Subjective effects questionnaire
Likert-type scale with responses ranging from 1 (not at all) to 7 (extremely). The following questions were asked: Did it make you dizzy? Did it make you nauseous? Did you enjoy it? Did it relieve the urge to smoke? Was it enough nicotine? Was it too much nicotine?
Time frame: 20 minutes after the start of product use
Incidence and nature of any adverse events (AE)
Incidence and nature of any adverse events (AE) (Safety and Tolerability)
Time frame: Through study completion, 6 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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