A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations

Fontem Ventures

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: myblu 25 mg nicotine salt; Other: blu PRO 48 mg nicotine salt; Other: myblu 25 mg freebase; Other: myblu 40 mg nicotine salt; Other: Conventional cigarette; Other: myblu 16 mg nicotine salt

Study type: Interventional

Funder types: Industry

Identifiers

NCT03822546

FON-01blu-2018

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Having smoked ≥10 manufactured cigarettes per day for at least the last year
• Expired carbon monoxide level of >10 ppm at screening
• Tested positive for urinary cotinine (≥500 ng/mL)

Exclusion criteria

• Known or suspected hypersensitivity to any component of the e-liquid formulations
• Taking or receiving prescription smoking cessation medicines
• Willing or considering to stop smoking
• Smokers who draw smoke into their mouth and throat but do not inhale
• Relevant illness history
• Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
• Breastfeeding women
• Women of child-bearing potential who were not using an accepted method of contraception

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 6 patient groups

Conventional cigarette

Experimental group

Description:

The subject's preferred brand of commercially available conventional cigarette

Treatment:

Other: Conventional cigarette

myblu 25 mg freebase

Active Comparator group

Description:

myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour

Treatment:

Other: myblu 25 mg freebase

myblu 16 mg nicotine salt

Active Comparator group

Description:

myblu pod-system containing 16 mg nicotine salt tobacco flavour

Treatment:

Other: myblu 16 mg nicotine salt

myblu 25 mg nicotine salt

Active Comparator group

Description:

myblu pod-system containing 25 mg nicotine salt tobacco flavour

Treatment:

Other: myblu 25 mg nicotine salt

myblu 40 mg nicotine salt

Active Comparator group

Description:

myblu pod-system containing 40 mg nicotine salt tobacco flavour

Treatment:

Other: myblu 40 mg nicotine salt

blu PRO 48 mg nicotine salt

Active Comparator group

Description:

blu PRO open-system containing 48 mg nicotine salt tobacco flavour

Treatment:

Other: blu PRO 48 mg nicotine salt