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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product A | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Cmax | Maximum measured plasma nicotine concentration, baseline-adjusted | 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 | 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: "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'. | 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 | Nothern Ireland | BT9 6AD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Product Sequence ABCD | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| 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 | Oct 29, 2021 | May 23, 2024 |
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| Product B | Other | 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) |
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| Product C | Other | 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) |
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| Product D | 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) |
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| 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'. |
| 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. | 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 |
| FG001 | Product Sequence BDAC | Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| FG002 | Product Sequence CADB | Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| FG003 | Product Sequence DCBA | Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Product Sequence ABCD | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| BG001 | Product Sequence BDAC | Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| BG002 | Product Sequence CADB | Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| BG003 | Product Sequence DCBA | Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4 Product A: 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 B: 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 C: 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 D: 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) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| 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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| 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 | |||||||||||||||||||||||||||||
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| Primary | Nicotine Cmax | Maximum measured plasma nicotine concentration, baseline-adjusted | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | 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, baseline-adjusted | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | 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: "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'. | 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: "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'. | Posted | Mean | Standard Deviation | units on a scale | At 240 min following the start of study product use |
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| Secondary | 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. | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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From screening until follow-up (7 days after the final product use)
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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) |
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| EG000 | Product A | Subjects using Product A (Heated Tobacco device Intense), for one product use session, 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) | 0 | 24 | 0 | 24 | 2 | 24 |
| EG001 | Product B | Subjects using Product B (Heated tobacco device Regular), for one product use session, 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) | 0 | 24 | 0 | 24 | 3 | 24 |
| EG002 | Product C | Subjects using Product C (Heated tobacco device menthol), for one product use session, 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) | 0 | 24 | 0 | 24 | 1 | 24 |
| EG003 | Product D | Subjects using Product D (subject's own brand combustible cigarette) for one product use session, 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) | 0 | 23 | 0 | 23 | 0 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
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| Libby Clarke | Imperial Brands PLC | +44 (0117) 3320221 | libby.clarke@impbrands.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2022 | May 23, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C476054 | HTR3D protein, human |
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| 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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| OG003 | Product D | Subjects using Product D (subject's own brand combustible cigarette) for one product use session, 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 | Subjects using Product D (subject's own brand combustible cigarette) for one product use session, 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 | Subjects using Product D (subject's own brand combustible cigarette) for one product use session, 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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| OG002 | Product C | Subjects using Product C (Heated tobacco device with menthol sticks), for one product use session, 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) |
| OG003 | Product D | Subjects using Product D (subject's own brand combustible cigarette) for one product use session, 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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