Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT05459857
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C476054', 'term': 'HTR3D protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'libby.clarke@impbrands.com', 'phone': '+44 (0117) 3320221', 'title': 'Libby Clarke', 'organization': 'Imperial Brands PLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From screening until follow-up (7 days after the final product use)', 'eventGroups': [{'id': 'EG000', 'title': 'Product A', 'description': '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)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Product B', 'description': '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)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Product C', 'description': '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)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Product D', 'description': "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)", 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nicotine Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'Subjects using Product A (Heated Tobacco device with Intense 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)'}, {'id': 'OG001', 'title': 'Product B', 'description': 'Subjects using Product B (Heated tobacco device with Regular 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)'}, {'id': 'OG002', 'title': 'Product C', 'description': '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)'}, {'id': 'OG003', 'title': 'Product D', 'description': "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)"}], 'classes': [{'categories': [{'measurements': [{'value': '10.500', 'spread': '8.284', 'groupId': 'OG000'}, {'value': '7.539', 'spread': '4.653', 'groupId': 'OG001'}, {'value': '8.191', 'spread': '4.447', 'groupId': 'OG002'}, {'value': '21.680', 'spread': '10.810', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'Maximum measured plasma nicotine concentration, baseline-adjusted', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Nicotine AUCt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'Subjects using Product A (Heated Tobacco device with Intense 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)'}, {'id': 'OG001', 'title': 'Product B', 'description': 'Subjects using Product B (Heated tobacco device with Regular 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)'}, {'id': 'OG002', 'title': 'Product C', 'description': '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)'}, {'id': 'OG003', 'title': 'Product D', 'description': "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)"}], 'classes': [{'categories': [{'measurements': [{'value': '746.00', 'spread': '271.24', 'groupId': 'OG000'}, {'value': '586.50', 'spread': '192.03', 'groupId': 'OG001'}, {'value': '585.00', 'spread': '191.16', 'groupId': 'OG002'}, {'value': '1514.00', 'spread': '368.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': 'The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, baseline-adjusted', 'unitOfMeasure': 'ng*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Urge to Smoke Pre-Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'Subjects using Product A (Heated Tobacco device with Intense 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)'}, {'id': 'OG001', 'title': 'Product B', 'description': 'Subjects using Product B (Heated tobacco device with Regular 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)'}, {'id': 'OG002', 'title': 'Product C', 'description': '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)'}, {'id': 'OG003', 'title': 'Product D', 'description': "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)"}], 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '30.9', 'groupId': 'OG001'}, {'value': '64.2', 'spread': '29.6', 'groupId': 'OG002'}, {'value': '62.8', 'spread': '30.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes prior to the start of the product use session', 'description': '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\'.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urge to Smoke Post-Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'Subjects using Product A (Heated Tobacco device with Intense 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)'}, {'id': 'OG001', 'title': 'Product B', 'description': 'Subjects using Product B (Heated tobacco device with Regular 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)'}, {'id': 'OG002', 'title': 'Product C', 'description': '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)'}, {'id': 'OG003', 'title': 'Product D', 'description': "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)"}], 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '67.5', 'spread': '26.3', 'groupId': 'OG001'}, {'value': '71.3', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '67.5', 'spread': '24.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 240 min following the start of study product use', 'description': '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\'.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Smoking Urges Emax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'Subjects using Product A (Heated Tobacco device with Intense 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)'}, {'id': 'OG001', 'title': 'Product B', 'description': 'Subjects using Product B (Heated tobacco device with Regular 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)'}, {'id': 'OG002', 'title': 'Product C', 'description': '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)'}, {'id': 'OG003', 'title': 'Product D', 'description': "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)"}], 'classes': [{'categories': [{'measurements': [{'value': '40.30', 'spread': '25.75', 'groupId': 'OG000'}, {'value': '32.90', 'spread': '27.13', 'groupId': 'OG001'}, {'value': '39.70', 'spread': '29.72', 'groupId': 'OG002'}, {'value': '49.80', 'spread': '30.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Product Sequence ABCD', 'description': "Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'FG001', 'title': 'Product Sequence BDAC', 'description': "Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'FG002', 'title': 'Product Sequence CADB', 'description': "Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'FG003', 'title': 'Product Sequence DCBA', 'description': "Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Product Sequence ABCD', 'description': "Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'BG001', 'title': 'Product Sequence BDAC', 'description': "Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'BG002', 'title': 'Product Sequence CADB', 'description': "Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'BG003', 'title': 'Product Sequence DCBA', 'description': "Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)\n\nProduct 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)"}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '12.75', 'groupId': 'BG000'}, {'value': '31.8', 'spread': '8.11', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '7.14', 'groupId': 'BG002'}, {'value': '42.2', 'spread': '12.5', 'groupId': 'BG003'}, {'value': '41.0', 'spread': '11.59', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-29', 'size': 3738827, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-23T05:03', 'hasProtocol': True}, {'date': '2022-01-13', 'size': 2439267, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-23T05:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2022-07-06', 'resultsFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-06', 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nicotine Cmax', 'timeFrame': '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', 'description': 'Maximum measured plasma nicotine concentration, baseline-adjusted'}, {'measure': 'Nicotine AUCt', 'timeFrame': '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', 'description': 'The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, baseline-adjusted'}], 'secondaryOutcomes': [{'measure': 'Urge to Smoke Pre-Use', 'timeFrame': '10 minutes prior to the start of the product use session', 'description': '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\'.'}, {'measure': 'Urge to Smoke Post-Use', 'timeFrame': 'At 240 min following the start of study product use', 'description': '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\'.'}, {'measure': 'Smoking Urges Emax', 'timeFrame': '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', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.\n\nSubjects will perform a screening visit and a 5-day confinement period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Has a positive urine cotinine (\\>500 ng/mL) at Screening\n* Has an exhaled carbon monoxide \\>10 ppm at Screening\n* A female subject of childbearing potential must use contraception\n* Male subject must use contraception\n\nExclusion Criteria:\n\n* 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.\n* Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening\n* Has a fever (\\>38.05°C) at Screening or check-in\n* Has a history or presence of drug or alcohol abuse within 24 months of Check-in\n* Pregnant or lactating females\n* Has used any prescription smoking cessation treatments within 3 months prior to Check-in\n* Is planning to quit smoking during the study or within the next 3 months'}, 'identificationModule': {'nctId': 'NCT05459857', 'briefTitle': 'A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imperial Brands PLC'}, 'officialTitle': 'A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes', 'orgStudyIdInfo': {'id': 'NER01/0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Product sequence ABCD', 'description': 'Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4', 'interventionNames': ['Other: Product A', 'Other: Product B', 'Other: Product C', 'Other: Product D']}, {'type': 'EXPERIMENTAL', 'label': 'Product sequence BDAC', 'description': 'Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4', 'interventionNames': ['Other: Product A', 'Other: Product B', 'Other: Product C', 'Other: Product D']}, {'type': 'EXPERIMENTAL', 'label': 'Product sequence CADB', 'description': 'Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4', 'interventionNames': ['Other: Product A', 'Other: Product B', 'Other: Product C', 'Other: Product D']}, {'type': 'EXPERIMENTAL', 'label': 'Product sequence DCBA', 'description': 'Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4', 'interventionNames': ['Other: Product A', 'Other: Product B', 'Other: Product C', 'Other: Product D']}], 'interventions': [{'name': 'Product A', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Product sequence ABCD', 'Product sequence BDAC', 'Product sequence CADB', 'Product sequence DCBA']}, {'name': 'Product B', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Product sequence ABCD', 'Product sequence BDAC', 'Product sequence CADB', 'Product sequence DCBA']}, {'name': 'Product C', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Product sequence ABCD', 'Product sequence BDAC', 'Product sequence CADB', 'Product sequence DCBA']}, {'name': 'Product D', 'type': 'OTHER', 'description': "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)", 'armGroupLabels': ['Product sequence ABCD', 'Product sequence BDAC', 'Product sequence CADB', 'Product sequence DCBA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 6AD', 'city': 'Belfast', 'state': 'Nothern Ireland', 'country': 'United Kingdom', 'facility': 'Celerion', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial Brands PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}