Healthy VolunteersNCT04891406
A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products
A study testing A, B and C in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in Sweden.
Trial summary
This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- A, B and C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2020to 20 Jan 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 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
- Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and >5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%
Who cannot join
- History of any clinically significant disease or disorder
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP
- Positive for HIV, hepatitis B or C
- After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure <90 or >140 mmHg, or
- Diastolic blood pressure <50 or >90 mmHg, or
Show all 12Show fewer
- Pulse <40 or >90 bpm
- Alcohol or drug abuse
- Use, or history of use of anabolic steroids
- Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
- Excessive caffeine consumption (daily intake of >5 cups)
- Female subjects who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products (Traditional Snus, Conventional Cigarette and Three Oral Tobacco-free Nicotine Delivery Products)
This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.
During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.
- Conditions
- Healthy Volunteers
- Being tested
- A, B, C, D, E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOther
Also called Product A
Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes
BOther
Also called Product B
Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes
COther
Also called Product C
Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes
DOther
Also called Product D
Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes
EOther
Also called Product E
Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| ABCDE | Other | Subjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5.
Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| BCDEA | Other | Same as previous arm but in a different randomization order. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| CDEAB | Other | Same as previous arm but in a different randomization order. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| DEABC | Other | Same as previous arm but in a different randomization order. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| EABCD | Other | Same as previous arm but in a different randomization order. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Cmax
Maximum plasma concentration of nicotine (Cmax)
Measured: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Nicotine AUCt
Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)
Measured: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Secondary outcomes (1)
Nicotine Extraction
Extraction fraction (%) of nicotine in used product pouches after 20 minutes of use.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jul 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT04891406
- Sponsor's protocol ID
- IB-OND-PKZX-01
- Status last verified
- Oct 2023
- First submitted
- 12 May 2021
- Last updated
- 13 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chapman F, McDermott S, Rudd K, Taverner V, Stevenson M, Chaudhary N, Reichmann K, Thompson J, Nahde T, O'Connell G. A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes. Psychopharmacology (Berl). 2022 Sep;239(9):2931-2943. doi: 10.1007/s00213-022-06178-6. Epub 2022 Jun 23.
PubMed 35732751
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products (Traditional Snus, Conventional Cigarette and Three Oral Tobacco-free Nicotine Delivery Products)
- ClinicalTrials.gov ID
- NCT04891406
- Acronym / sponsor ID
- IB-OND-PKZX-01
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Imperial Brands PLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Posted 13 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.
During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ABCDE | Other | Other: A, Other: B, Other: C, Other: D, Other: ESubjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5. Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight. |
| BCDEA | Other | Other: A, Other: B, Other: C, Other: D, Other: ESame as previous arm but in a different randomization order. |
| CDEAB | Other | Other: A, Other: B, Other: C, Other: D, Other: ESame as previous arm but in a different randomization order. |
| DEABC | Other | Other: A, Other: B, Other: C, Other: D, Other: ESame as previous arm but in a different randomization order. |
| EABCD | Other | Other: A, Other: B, Other: C, Other: D, Other: ESame as previous arm but in a different randomization order. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
- Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and >5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%
Key exclusion criteria (12 listed)
- History of any clinically significant disease or disorder
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP
- Positive for HIV, hepatitis B or C
- After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Alcohol or drug abuse
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 |
|---|---|---|
| AAlso: Product AUse of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes | Other | ABCDE, BCDEA, CDEAB, DEABC, EABCD |
| BAlso: Product BUse of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes | Other | ABCDE, BCDEA, CDEAB, DEABC, EABCD |
| CAlso: Product CUse of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes | Other | ABCDE, BCDEA, CDEAB, DEABC, EABCD |
| DAlso: Product DUse of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes | Other | ABCDE, BCDEA, CDEAB, DEABC, EABCD |
| EAlso: Product EUse of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes | Other | ABCDE, BCDEA, CDEAB, DEABC, EABCD |
Primary outcome
Nicotine Cmax
Time frame: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Maximum plasma concentration of nicotine (Cmax)
Nicotine AUCt
Time frame: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)
1 secondary outcome
Nicotine Extraction
Time frame: 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35732751Chapman F, McDermott S, Rudd K, Taverner V, Stevenson M, Chaudhary N, Reichmann K, Thompson J, Nahde T, O'Connell G. A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes. Psychopharmacology (Berl). 2022 Sep;239(9):2931-2943. doi: 10.1007/s00213-022-06178-6. Epub 2022 Jun 23.
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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 A, B and C in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in Sweden.
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 12 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 13 Oct 2023. 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 Sweden. 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 13 Oct 2023). 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: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start). 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?
On the ClinicalTrials.gov record for NCT04891406, which also lists 1 linked publication.
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 13 Oct 2023.