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This is a randomised, cross-over, open-label, confinement study conducted in 25 adult male or female smokers of combustible cigarettes (CCs). The study investigates combustible cigarettes, heated tobacco products (HTPs), and Heated Herbal Products (HHPs), with endpoints including pharmacokinetic evaluation, and subjective effects.
Subjects will perform a Screening Visit and one Study Visit, including a 6-day confinement period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product use sequence ABECD | Experimental | Subjects use Product A on Day 1, Product B on Day 2, Product E on Day 3 and Product C on Day 4 and Product D on Day 5. |
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| Product use sequence BCADE | Experimental | Subjects use Product B on Day 1, Product C on Day 2, Product A on Day 3 and Product D on Day 4 and Product E on Day 5. |
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| Product use sequence CDBEA | Experimental | Subjects use Product C on Day 1, Product D on Day 2, Product B on Day 3 and Product E on Day 4 and Product A on Day 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated tobacco product with heated tobacco sticks (Product A) | Other | Product A, 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), followed by an ad-libitum, 4-hour product use session on the same day. |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Cmax | Maximum measured plasma nicotine concentration, following the controlled product use session | 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, following the controlled product use session | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Urge to Smoke Pre-use | The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'. | 10 minutes prior to the start of the product use session |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Belfast | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Product Use Sequence ABECD | Subjects use Product A on Day 1, Product B on Day 2, Product E on Day 3 and Product C on Day 4 and Product D on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2023 | May 21, 2024 |
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| Product use sequence DECAB |
| Experimental |
Subjects use Product D on Day 1, Product E on Day 2, Product C on Day 3 and Product A on Day 4 and Product B on Day 5. |
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| Product use sequence EADBC | Experimental | Subjects use Product E on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 and Product C on Day 5. |
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| Heated tobacco product with heated tobacco sticks (Product B) | Other | Product B, 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), followed by an ad-libitum, 4-hour product use session on the same day. |
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| Heated herbal product with nicotine-infused heated herbal sticks (Product C) | Other | Product C, 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), followed by an ad-libitum, 4-hour product use session on the same day. |
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| Heated herbal product with nicotine-infused heated herbal sticks (Product D) | Other | Product D, 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), followed by an ad-libitum, 4-hour product use session on the same day. |
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| Conventional Cigarette (Product E) | Other | 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), followed by an ad-libitum, 4-hour product use session on the same day. |
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| Urge to Smoke Post-use |
The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'. |
| At 240 minutes following the start of study product use |
| Urge to Smoke Emax | The subjects self-assess their urge to smoke at defined time points by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'A great deal'. Emax is calculated as the maximum absolute value of change from baseline (pre-use) (i.e., the maximum response) in VAS scores. | 10 minutes prior to the start of the product use session and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use. |
| Puff Count | Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session | Hours 2-4 of the 4-hour ad libitum product use session |
| Product Use Sequence BCADE |
Subjects use Product B on Day 1, Product C on Day 2, Product A on Day 3 and Product D on Day 4 and Product E on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| FG002 | Product Use Sequence CDBEA | Subjects use Product C on Day 1, Product D on Day 2, Product B on Day 3 and Product E on Day 4 and Product A on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| FG003 | Product Use Sequence DECAB | Subjects use Product D on Day 1, Product E on Day 2, Product C on Day 3 and Product A on Day 4 and Product B on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| FG004 | Product Use Sequence EADBC | Subjects use Product E on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 and Product C on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
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| ID | Title | Description |
|---|---|---|
| BG000 | Product Use Sequence ABECD | Subjects use Product A on Day 1, Product B on Day 2, Product E on Day 3 and Product C on Day 4 and Product D on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| BG001 | Product Use Sequence BCADE | Subjects use Product B on Day 1, Product C on Day 2, Product A on Day 3 and Product D on Day 4 and Product E on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| BG002 | Product Use Sequence CDBEA | Subjects use Product C on Day 1, Product D on Day 2, Product B on Day 3 and Product E on Day 4 and Product A on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| BG003 | Product Use Sequence DECAB | Subjects use Product D on Day 1, Product E on Day 2, Product C on Day 3 and Product A on Day 4 and Product B on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| BG004 | Product Use Sequence EADBC | Subjects use Product E on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 and Product C on Day 5. On each day, subjects completely use one single unit of the product (one stick, approximately 10 puffs, with 30-second interpuff intervals). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nicotine Cmax | Maximum measured plasma nicotine concentration, following the controlled product use session | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Nicotine AUCt | The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, following the controlled product use session | Posted | Mean | Standard Deviation | ng*min/mL | 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 |
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| Secondary | Urge to Smoke Pre-use | The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'. | Posted | Mean | Standard Deviation | units on a scale | 10 minutes prior to the start of the product use session |
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| Secondary | Urge to Smoke Post-use | The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'. | Posted | Mean | Standard Deviation | units on a scale | At 240 minutes following the start of study product use |
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| Secondary | Urge to Smoke Emax | The subjects self-assess their urge to smoke at defined time points by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'A great deal'. Emax is calculated as the maximum absolute value of change from baseline (pre-use) (i.e., the maximum response) in VAS scores. | Posted | Mean | Standard Deviation | units on a scale | 10 minutes prior to the start of the product use session and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use. |
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| Secondary | Puff Count | Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session | Topography parameters were only available for subsets of subjects due to technical issues with the puff topography analyser during the data recording process, which resulted in incomplete data capture for some participants. | Posted | Mean | Standard Deviation | number of puffs | Hours 2-4 of the 4-hour ad libitum product use session |
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From Screening until follow-up visit 7 days after final product use (total of approx. 2 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Product A | All subjects having used Product A throughout the study. | 0 | 25 | 0 | 25 | 4 | 25 |
| EG001 | Product B | All subjects having used Product B throughout the study. | 0 | 25 | 0 | 25 | 6 | 25 |
| EG002 | Product C | All subjects having used Product C throughout the study. | 0 | 25 | 0 | 25 | 5 | 25 |
| EG003 | Product D | All subjects having used Product D throughout the study. | 0 | 25 | 0 | 25 | 3 | 25 |
| EG004 | Product E | All subjects having used Product E throughout the study. | 0 | 25 | 0 | 25 | 7 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Catheter site irritation | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Catheter site rash | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tasnim Abusalem | Imperial Brands PLC | +44 (0) 117 332 2343 | tasnim.abusalem@impbrands.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2023 | May 23, 2024 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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All subjects after having used Product D 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)
| OG004 | Product E | All subjects after having used Product E 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) |
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All subjects after having used Product D 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)
| OG004 | Product E | All subjects after having used Product E 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) |
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All subjects after having used Product D 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)
| OG004 | Product E | All subjects after having used Product E 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) |
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| OG003 | Product D | All subjects after having used Product D 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) |
| OG004 | Product E | All subjects after having used Product E 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) |
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| OG004 | Product E | All subjects after having used Product E during last 2 hours of the 4-hour ad libitum product use session. |
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