Healthy VolunteersNCT05459857
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
A study testing Product A, Product B and Product C in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in United Kingdom.
Trial summary
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes. The study investigates combustible and heated tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation, subjective questionnaire assessments, as well as… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Product A, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
- Has a positive urine cotinine (>500 ng/mL) at Screening
- Has an exhaled carbon monoxide >10 ppm at Screening
- A female subject of childbearing potential must use contraception
- Male subject must use contraception
Who cannot join
- Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
- Has a fever (>38.05°C) at Screening or check-in
- Has a history or presence of drug or alcohol abuse within 24 months of Check-in
- Pregnant or lactating females
- Has used any prescription smoking cessation treatments within 3 months prior to Check-in
- Is planning to quit smoking during the study or within the next 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes. The study investigates combustible and heated tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation, subjective questionnaire assessments, as well as safety evaluation.
Subjects will perform a screening visit and a 5-day confinement period.
- Conditions
- Healthy Volunteers
- Being tested
- Product A, Product B, Product C, Product D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
Heated tobacco (HT) device with Intense HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Product BOther
Heated tobacco (HT) device with Regular HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Product COther
Heated tobacco (HT) device with Menthol HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Product DOther
Subject's own brand combustible cigarette, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
| Study group | Role | What they receive |
|---|---|---|
| Product sequence ABCD | Experimental | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
| Product sequence BDAC | Experimental | Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
| Product sequence CADB | Experimental | Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
| Product sequence DCBA | Experimental | Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Cmax
Maximum measured plasma nicotine concentration, baseline-adjusted
Measured: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Nicotine AUCt
The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, baseline-adjusted
Measured: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Secondary outcomes (3)
Urge to Smoke Pre-Use
The subjects self-assess their urge to smoke by answering the question: "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'extreme'.
Measured: 10 minutes prior to the start of the product use session
Urge to Smoke Post-Use
The subjects self-assess their urge to smoke by answering the question: "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'extreme'.
Measured: At 240 min following the start of study product use
Smoking Urges Emax
The subjects self-assess their urge to smoke at defined time points by answering the question: "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'extreme'. Emax is calculated as the maximum absolute value of change from baseline (i.e., the maximum response) in VAS scores.
Measured: 10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 210 and 240 minutes following the start of study product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Oct 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial Brands PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459857
- Sponsor's protocol ID
- NER01/0004
- Status last verified
- Jan 2025
- First submitted
- 6 Jul 2022
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
- ClinicalTrials.gov ID
- NCT05459857
- Acronym / sponsor ID
- NER01/0004
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Imperial Brands PLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes. The study investigates combustible and heated tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation, subjective questionnaire assessments, as well as safety evaluation.
Subjects will perform a screening visit and a 5-day confinement period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Product sequence ABCD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 |
| Product sequence BDAC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4 |
| Product sequence CADB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 |
| Product sequence DCBA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
- Has a positive urine cotinine (>500 ng/mL) at Screening
- Has an exhaled carbon monoxide >10 ppm at Screening
- A female subject of childbearing potential must use contraception
- Male subject must use contraception
Key exclusion criteria (7 listed)
- Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
- Has a fever (>38.05°C) at Screening or check-in
- Has a history or presence of drug or alcohol abuse within 24 months of Check-in
- Pregnant or lactating females
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 |
|---|---|---|
| Product AHeated tobacco (HT) device with Intense HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) | Other | Product sequence ABCD, Product sequence BDAC, Product sequence CADB, Product sequence DCBA |
| Product BHeated tobacco (HT) device with Regular HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) | Other | Product sequence ABCD, Product sequence BDAC, Product sequence CADB, Product sequence DCBA |
| Product CHeated tobacco (HT) device with Menthol HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) | Other | Product sequence ABCD, Product sequence BDAC, Product sequence CADB, Product sequence DCBA |
| Product DSubject's own brand combustible cigarette, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration) | Other | Product sequence ABCD, Product sequence BDAC, Product sequence CADB, Product sequence DCBA |
Primary outcome
Nicotine Cmax
Time frame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Maximum measured plasma nicotine concentration, baseline-adjusted
Nicotine AUCt
Time frame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, baseline-adjusted
3 secondary outcomes
Urge to Smoke Pre-Use
Time frame: 10 minutes prior to the start of the product use session
Urge to Smoke Post-Use
Time frame: At 240 min following the start of study product use
Smoking Urges Emax
Time frame: 10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 210 and 240 minutes following the start of study product use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Product A, Product B and Product C in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in United Kingdom.
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 5 inclusion and 7 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 3 Feb 2025. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cmax (time frame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use). The study lists 2 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 3 Feb 2025.