Healthy VolunteersNCT03822546
A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
A study testing Conventional cigarette, myblu 25 mg freebase and myblu 16 mg nicotine salt in people with Healthy Volunteers, run by Fontem Ventures BV at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Conventional cigarette, myblu 25 mg freebase and myblu 16 mg nicotine salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers
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.
- Conditions
- Healthy Volunteers
- Being tested
- Conventional cigarette, myblu 25 mg freebase, myblu 16 mg nicotine salt, myblu 25 mg nicotine salt, myblu 40 mg nicotine salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional cigaretteOther
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
myblu 25 mg freebaseOther
E-cigarette used for 10 inhalations every 30 seconds
myblu 16 mg nicotine saltOther
E-cigarette used for 10 inhalations every 30 seconds
myblu 25 mg nicotine saltOther
E-cigarette used for 10 inhalations every 30 seconds
myblu 40 mg nicotine saltOther
E-cigarette used for 10 inhalations every 30 seconds
blu PRO 48 mg nicotine saltOther
E-cigarette used for 10 inhalations every 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Conventional cigarette | Experimental | The subject's preferred brand of commercially available conventional cigarette Receives: Other: Conventional cigarette |
| myblu 25 mg freebase | Active comparator | myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour Receives: Other: myblu 25 mg freebase |
| myblu 16 mg nicotine salt | Active comparator | myblu pod-system containing 16 mg nicotine salt tobacco flavour Receives: Other: myblu 16 mg nicotine salt |
| myblu 25 mg nicotine salt | Active comparator | myblu pod-system containing 25 mg nicotine salt tobacco flavour Receives: Other: myblu 25 mg nicotine salt |
| myblu 40 mg nicotine salt | Active comparator | myblu pod-system containing 40 mg nicotine salt tobacco flavour Receives: Other: myblu 40 mg nicotine salt |
| blu PRO 48 mg nicotine salt | Active comparator | blu PRO open-system containing 48 mg nicotine salt tobacco flavour Receives: Other: blu PRO 48 mg nicotine salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine pharmacokinetics Cmax
Mean maximum plasma nicotine concentration (Cmax)
Measured: 30 minutes following the start of product use (12 measurements over the period)
Nicotine pharmacokinetics Tmax
Median time to maximum plasma nicotine concentration (Tmax)
Measured: 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)
Measured: 30 minutes following the start of product use (12 measurements over the period)
Secondary outcomes (2)
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?
Measured: 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)
Measured: Through study completion, 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Apr 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fontem Ventures BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822546
- Sponsor's protocol ID
- FON-01blu-2018
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers
- ClinicalTrials.gov ID
- NCT03822546
- Acronym / sponsor ID
- FON-01blu-2018
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fontem Ventures BVIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Conventional cigarette | Experimental | Other: Conventional cigaretteThe subject's preferred brand of commercially available conventional cigarette |
| myblu 25 mg freebase | Active comparator | Other: myblu 25 mg freebasemyblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour |
| myblu 16 mg nicotine salt | Active comparator | Other: myblu 16 mg nicotine saltmyblu pod-system containing 16 mg nicotine salt tobacco flavour |
| myblu 25 mg nicotine salt | Active comparator | Other: myblu 25 mg nicotine saltmyblu pod-system containing 25 mg nicotine salt tobacco flavour |
| myblu 40 mg nicotine salt | Active comparator | Other: myblu 40 mg nicotine saltmyblu pod-system containing 40 mg nicotine salt tobacco flavour |
| blu PRO 48 mg nicotine salt | Active comparator | Other: blu PRO 48 mg nicotine saltblu PRO open-system containing 48 mg nicotine salt tobacco flavour |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional cigaretteSubject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals | Other | Conventional cigarette |
| myblu 25 mg freebaseE-cigarette used for 10 inhalations every 30 seconds | Other | myblu 25 mg freebase |
| myblu 16 mg nicotine saltE-cigarette used for 10 inhalations every 30 seconds | Other | myblu 16 mg nicotine salt |
| myblu 25 mg nicotine saltE-cigarette used for 10 inhalations every 30 seconds | Other | myblu 25 mg nicotine salt |
| myblu 40 mg nicotine saltE-cigarette used for 10 inhalations every 30 seconds | Other | myblu 40 mg nicotine salt |
| blu PRO 48 mg nicotine saltE-cigarette used for 10 inhalations every 30 seconds | Other | blu PRO 48 mg nicotine salt |
Primary outcome
Nicotine pharmacokinetics Cmax
Time frame: 30 minutes following the start of product use (12 measurements over the period)
Mean maximum plasma nicotine concentration (Cmax)
Nicotine pharmacokinetics Tmax
Time frame: 30 minutes following the start of product use (12 measurements over the period)
Median time to maximum plasma nicotine concentration (Tmax)
Nicotine pharmacokinetics AUC0-30
Time frame: 30 minutes following the start of product use (12 measurements over the period)
Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)
2 secondary outcomes
Subjective effects questionnaire
Time frame: 20 minutes after the start of product use
Incidence and nature of any adverse events (AE)
Time frame: Through study completion, 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional cigarette, myblu 25 mg freebase and myblu 16 mg nicotine salt in people with Healthy Volunteers, run by Fontem Ventures BV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine pharmacokinetics Cmax (time frame: 30 minutes following the start of product use (12 measurements over the period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.