Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 4:41 PM
Study NCT ID:
NCT06093659
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tasnim.abusalem@impbrands.com', 'phone': '+44 (0) 117 332 2343', 'title': 'Tasnim Abusalem', 'organization': 'Imperial Brands PLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Screening until follow-up visit 7 days after final product use (total of approx. 2 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Product A', 'description': 'All subjects having used Product A throughout the study.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Product B', 'description': 'All subjects having used Product B throughout the study.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Product C', 'description': 'All subjects having used Product C throughout the study.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 5, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Product D', 'description': 'All subjects having used Product D throughout the study.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 3, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Product E', 'description': 'All subjects having used Product E throughout the study.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Catheter site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Catheter site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Catheter site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nicotine Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'All subjects after having used Product A 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': 'All subjects after having used Product B 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': 'All subjects after having used Product C 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': '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)'}, {'id': 'OG004', 'title': 'Product E', 'description': '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)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.00', 'spread': '9.80', 'groupId': 'OG000'}, {'value': '12.97', 'spread': '7.10', 'groupId': 'OG001'}, {'value': '6.00', 'spread': '3.28', 'groupId': 'OG002'}, {'value': '6.87', 'spread': '3.24', 'groupId': 'OG003'}, {'value': '18.51', 'spread': '10.05', 'groupId': 'OG004'}]}]}], '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, following the controlled product use session', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Nicotine AUCt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'All subjects after having used Product A 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': 'All subjects after having used Product B 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': 'All subjects after having used Product C 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': '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)'}, {'id': 'OG004', 'title': 'Product E', 'description': '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)'}], 'classes': [{'categories': [{'measurements': [{'value': '716.3', 'spread': '329.6', 'groupId': 'OG000'}, {'value': '777.0', 'spread': '289.4', 'groupId': 'OG001'}, {'value': '363.9', 'spread': '123.8', 'groupId': 'OG002'}, {'value': '382.5', 'spread': '145.0', 'groupId': 'OG003'}, {'value': '1144.0', 'spread': '427.9', 'groupId': 'OG004'}]}]}], '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, following the controlled product use session', 'unitOfMeasure': 'ng*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urge to Smoke Pre-use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'All subjects after having used Product A 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': 'All subjects after having used Product B 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': 'All subjects after having used Product C 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': '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)'}, {'id': 'OG004', 'title': 'Product E', 'description': '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)'}], 'classes': [{'categories': [{'measurements': [{'value': '93.6', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '94.0', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '92.9', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '91.9', 'spread': '13.0', 'groupId': 'OG003'}, {'value': '90.0', 'spread': '17.8', 'groupId': 'OG004'}]}]}], '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: "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\'.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urge to Smoke Post-use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'All subjects after having used Product A 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': 'All subjects after having used Product B 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': 'All subjects after having used Product C 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': '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)'}, {'id': 'OG004', 'title': 'Product E', 'description': '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)'}], 'classes': [{'categories': [{'measurements': [{'value': '91.4', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '90.7', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '88.7', 'spread': '15.5', 'groupId': 'OG002'}, {'value': '88.3', 'spread': '18.6', 'groupId': 'OG003'}, {'value': '87.6', 'spread': '18.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 240 minutes following the start of study product use', 'description': '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\'.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urge to Smoke Emax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'All subjects after having used Product A 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': 'All subjects after having used Product B 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': 'All subjects after having used Product C 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': '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)'}, {'id': 'OG004', 'title': 'Product E', 'description': '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)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '64.4', 'spread': '29.0', 'groupId': 'OG001'}, {'value': '43.0', 'spread': '31.7', 'groupId': 'OG002'}, {'value': '44.3', 'spread': '28.9', 'groupId': 'OG003'}, {'value': '69.2', 'spread': '28.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Puff Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Product A', 'description': 'All subjects after having used Product A during last 2 hours of the 4-hour ad libitum product use session.'}, {'id': 'OG001', 'title': 'Product B', 'description': 'All subjects after having used Product B during last 2 hours of the 4-hour ad libitum product use session.'}, {'id': 'OG002', 'title': 'Product C', 'description': 'All subjects after having used Product C during last 2 hours of the 4-hour ad libitum product use session.'}, {'id': 'OG003', 'title': 'Product D', 'description': 'All subjects after having used Product D during last 2 hours of the 4-hour ad libitum product use session.'}, {'id': 'OG004', 'title': 'Product E', 'description': 'All subjects after having used Product E during last 2 hours of the 4-hour ad libitum product use session.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '20.8', 'groupId': 'OG002'}, {'value': '31.9', 'spread': '13.7', 'groupId': 'OG003'}, {'value': '20.2', 'spread': '10.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hours 2-4 of the 4-hour ad libitum product use session', 'description': 'Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session', 'unitOfMeasure': 'number of puffs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Product Use Sequence ABECD', 'description': '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).'}, {'id': 'FG001', 'title': 'Product Use Sequence BCADE', 'description': '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).'}, {'id': 'FG002', 'title': 'Product Use Sequence CDBEA', 'description': '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).'}, {'id': 'FG003', 'title': 'Product Use Sequence DECAB', 'description': '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).'}, {'id': 'FG004', 'title': 'Product Use Sequence EADBC', 'description': '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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Product Use Sequence ABECD', 'description': '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).'}, {'id': 'BG001', 'title': 'Product Use Sequence BCADE', 'description': '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).'}, {'id': 'BG002', 'title': 'Product Use Sequence CDBEA', 'description': '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).'}, {'id': 'BG003', 'title': 'Product Use Sequence DECAB', 'description': '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).'}, {'id': 'BG004', 'title': 'Product Use Sequence EADBC', 'description': '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).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '9.91', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '8.62', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '8.70', 'groupId': 'BG002'}, {'value': '36.4', 'spread': '12.58', 'groupId': 'BG003'}, {'value': '37.8', 'spread': '6.06', 'groupId': 'BG004'}, {'value': '40.6', 'spread': '9.38', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.46', 'spread': '3.11', 'groupId': 'BG000'}, {'value': '25.43', 'spread': '1.57', 'groupId': 'BG001'}, {'value': '25.63', 'spread': '3.85', 'groupId': 'BG002'}, {'value': '22.80', 'spread': '2.72', 'groupId': 'BG003'}, {'value': '26.15', 'spread': '3.34', 'groupId': 'BG004'}, {'value': '25.10', 'spread': '3.00', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-07', 'size': 1903402, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-21T07:18', 'hasProtocol': True}, {'date': '2023-11-09', 'size': 2804869, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-23T05:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2023-10-10', 'resultsFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-06', 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-03', '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, following the controlled product use session'}, {'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, following the controlled product use session'}], '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: "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\'.'}, {'measure': 'Urge to Smoke Post-use', 'timeFrame': 'At 240 minutes following the start of study product use', 'description': '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\'.'}, {'measure': 'Urge to Smoke Emax', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Puff Count', 'timeFrame': 'Hours 2-4 of the 4-hour ad libitum product use session', 'description': 'Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.\n\nSubjects will perform a Screening Visit and one Study Visit, including a 6-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* Female subjects of childbearing potential must use contraception\n* Male subjects 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 body mass index (BMI) \\> 30.0 kg/m\\^2 or \\< 18.0 kg/m\\^2 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 Is planning to quit smoking during the study or within the next 3 months'}, 'identificationModule': {'nctId': 'NCT06093659', 'briefTitle': 'Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imperial Brands PLC'}, 'officialTitle': 'A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco and Heated Herbal Products Compared With Combustible Cigarettes', 'orgStudyIdInfo': {'id': 'NER 01/005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Product use sequence ABECD', 'description': '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.', 'interventionNames': ['Other: Heated tobacco product with heated tobacco sticks (Product A)', 'Other: Heated tobacco product with heated tobacco sticks (Product B)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)', 'Other: Conventional Cigarette (Product E)']}, {'type': 'EXPERIMENTAL', 'label': 'Product use sequence BCADE', 'description': '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.', 'interventionNames': ['Other: Heated tobacco product with heated tobacco sticks (Product A)', 'Other: Heated tobacco product with heated tobacco sticks (Product B)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)', 'Other: Conventional Cigarette (Product E)']}, {'type': 'EXPERIMENTAL', 'label': 'Product use sequence CDBEA', 'description': '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.', 'interventionNames': ['Other: Heated tobacco product with heated tobacco sticks (Product A)', 'Other: Heated tobacco product with heated tobacco sticks (Product B)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)', 'Other: Conventional Cigarette (Product E)']}, {'type': 'EXPERIMENTAL', 'label': 'Product use sequence DECAB', 'description': '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.', 'interventionNames': ['Other: Heated tobacco product with heated tobacco sticks (Product A)', 'Other: Heated tobacco product with heated tobacco sticks (Product B)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)', 'Other: Conventional Cigarette (Product E)']}, {'type': 'EXPERIMENTAL', 'label': 'Product use sequence EADBC', 'description': '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.', 'interventionNames': ['Other: Heated tobacco product with heated tobacco sticks (Product A)', 'Other: Heated tobacco product with heated tobacco sticks (Product B)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)', 'Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)', 'Other: Conventional Cigarette (Product E)']}], 'interventions': [{'name': 'Heated tobacco product with heated tobacco sticks (Product A)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Product use sequence ABECD', 'Product use sequence BCADE', 'Product use sequence CDBEA', 'Product use sequence DECAB', 'Product use sequence EADBC']}, {'name': 'Heated tobacco product with heated tobacco sticks (Product B)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Product use sequence ABECD', 'Product use sequence BCADE', 'Product use sequence CDBEA', 'Product use sequence DECAB', 'Product use sequence EADBC']}, {'name': 'Heated herbal product with nicotine-infused heated herbal sticks (Product C)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Product use sequence ABECD', 'Product use sequence BCADE', 'Product use sequence CDBEA', 'Product use sequence DECAB', 'Product use sequence EADBC']}, {'name': 'Heated herbal product with nicotine-infused heated herbal sticks (Product D)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Product use sequence ABECD', 'Product use sequence BCADE', 'Product use sequence CDBEA', 'Product use sequence DECAB', 'Product use sequence EADBC']}, {'name': 'Conventional Cigarette (Product E)', '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), followed by an ad-libitum, 4-hour product use session on the same day.", 'armGroupLabels': ['Product use sequence ABECD', 'Product use sequence BCADE', 'Product use sequence CDBEA', 'Product use sequence DECAB', 'Product use sequence EADBC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Celerion', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial Brands PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}