Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-05 @ 5:40 PM
Study NCT ID:
NCT01967732
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2013-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christelle.Haziza@pmi.com', 'phone': '+41 (58) 242 2625', 'title': 'Christelle HAZIZA, PhD', 'organization': 'Philip Morris Products S.A.'}, 'certainAgreement': {'otherDetails': "We confirm we have the contractual provisions in place which specifies that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.\n\nThe Intellectual Property rights and research results from the present study belongs to the Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the informed consent form (ICF( signature until the end of the safety follow-up period (7 days after discharge of the subject)', 'description': 'The safety was assessed in the safety population, consisting of 62 subjects: 44 subjects in Group 1, 18 subjects in Group 2. This population includes all the subjects exposed to THS 2.2 and NNS from the product trials on Day -1.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'This population comprises the following sequences:\n\n* Sequence "THS 2.2 then CC"\n* Sequence "CC then THS 2.2"', 'otherNumAtRisk': 44, 'otherNumAffected': 15, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'This population comprises the following sequences:\n\n* Sequence "THS 2.2 then NNS"\n* Sequence "NNS then THS 2.2"', 'otherNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 - Group 1', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then CC"\n* Sequence "CC then THS 2.2"'}, {'id': 'OG001', 'title': 'CC - Group 1', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then CC"\n* Sequence "CC then THS 2.2"'}, {'id': 'OG002', 'title': 'THS 2.2 - Group 2', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then NNS"\n* Sequence "NNS then THS 2.2"'}, {'id': 'OG003', 'title': 'NNS - Group 2', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then NNS"\n* Sequence "NNS then THS 2.2"'}], 'classes': [{'categories': [{'measurements': [{'value': '9.62', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '11.17'}, {'value': '12.42', 'groupId': 'OG001', 'lowerLimit': '10.69', 'upperLimit': '14.42'}, {'value': '10.52', 'groupId': 'OG002', 'lowerLimit': '7.91', 'upperLimit': '13.98'}, {'value': '3.51', 'groupId': 'OG003', 'lowerLimit': '2.63', 'upperLimit': '4.66'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.43', 'ciLowerLimit': '62.69', 'ciUpperLimit': '95.63', 'estimateComment': 'LS mean ratio (THS 2.2 - Group 1:CC - Group 1)', 'groupDescription': 'The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 days', 'description': 'Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).\n\nGeometric Least Squares means are provided.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'THS 2.2 - Group 1', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then CC"\n* Sequence "CC then THS 2.2"'}, {'id': 'OG001', 'title': 'CC - Group 1', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then CC"\n* Sequence "CC then THS 2.2"'}, {'id': 'OG002', 'title': 'THS 2.2 - Group 2', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then NNS"\n* Sequence "NNS then THS 2.2"'}, {'id': 'OG003', 'title': 'NNS - Group 2', 'description': 'The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:\n\n* Sequence "THS 2.2 then NNS"\n* Sequence "NNS then THS 2.2"'}], 'classes': [{'categories': [{'measurements': [{'value': '15.10', 'groupId': 'OG000', 'lowerLimit': '13.19', 'upperLimit': '17.29'}, {'value': '20.28', 'groupId': 'OG001', 'lowerLimit': '17.71', 'upperLimit': '23.22'}, {'value': '17.87', 'groupId': 'OG002', 'lowerLimit': '13.79', 'upperLimit': '23.15'}, {'value': '8.02', 'groupId': 'OG003', 'lowerLimit': '6.19', 'upperLimit': '10.39'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '74.47', 'ciLowerLimit': '61.52', 'ciUpperLimit': '90.14', 'estimateComment': 'LS mean ratio (THS 2.2 - Group 1:CC - Group 1)', 'groupDescription': 'The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 days', 'description': 'Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).\n\nGeometric Least Squares means are provided.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'THS 2.2 Then CC', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single product use of THS 2.2)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of CC).'}, {'id': 'FG001', 'title': 'CC Then THS 2.2', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single product use of CC)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of THS 2.2).'}, {'id': 'FG002', 'title': 'THS 2.2 Then NNS', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single product use of THS 2.2)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single administration of NNS)'}, {'id': 'FG003', 'title': 'NNS Then THS 2.2', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single administration of NNS)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of THS 2.2).'}], 'periods': [{'title': 'Washout Period of 1 Day (Day 0)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Dropped due to personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'First Intervention (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'Subject discontinued from the study prior to product use', 'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Poor venous access', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 1 Day (Day 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (Day 3)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study initiated (first subject screened): 01 November 2013\n\nAt admission (Day -1), all the subjects performed a product trial (THS 2.2 and subsequently NNS).\n\nFrom enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences.', 'preAssignmentDetails': 'Enrolled population = 62 subjects = 62 randomized as described below:\n\n* Sequence "THS 2.2 then CC": 22 subjects\n* Sequence "CC then THS 2.2": 22 subjects\n* Sequence "THS 2.2 then NNS": 9 subjects\n* Sequence "NNS then THS 2.2": 9 subjects'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'This population comprises the following sequences:\n\n* Sequence "THS 2.2 then CC"\n* Sequence "CC then THS 2.2"'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'This population comprises the following sequences:\n\n* Sequence "THS 2.2 then NNS"\n* Sequence "NNS then THS 2.2"'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '8.98', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '5.80', 'groupId': 'BG001'}, {'value': '31.7', 'spread': '8.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'International Organization for Standardization (ISO) nicotine level', 'classes': [{'title': '≤ 0.6 mg', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': '> 0.6 to ≤ 1 mg', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'PK population: all randomized subjects who completed at least 1 of the single-use days, with at least 1 derived PK parameter. No subjects were excluded due to major protocol deviations impacting the evaluation of the results.\n\n62 randomized: 44 in Group 1, 18 in Group 2\n\n60 completers: 42 in Group 1 (2 discontinued), 18 in Group 2'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-11', 'size': 12324194, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-02T04:33', 'hasProtocol': True}, {'date': '2014-05-08', 'size': 4231519, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-02T04:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2013-10-18', 'resultsFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2013-10-18', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-01', 'studyFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS', 'timeFrame': '3 days', 'description': 'Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).\n\nGeometric Least Squares means are provided.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS', 'timeFrame': '3 days', 'description': 'Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).\n\nGeometric Least Squares means are provided.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'Nicotine absorption', 'Modified risk tobacco product', 'Conventional cigarette', 'Nicotine replacement therapy', 'Nicotine nasal spray'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is Caucasian\n* Smoking, healthy subject as judged by the Investigator.\n* Subject has smoked at least 10 commercially available non menthol CCs per day (no brand restrictions) for the last 4 weeks.\n* Subject has smoked for at least the last 3 consecutive years.\n* Subject does not plan to quit smoking in the next 3 months.\n\nExclusion Criteria:\n\n* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).\n* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.\n* Female subject is pregnant or breast feeding.\n* Female subject does not agree to use an acceptable method of effective contraception.'}, 'identificationModule': {'nctId': 'NCT01967732', 'briefTitle': 'Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.', 'orgStudyIdInfo': {'id': 'ZRHR-PK-01-EU'}, 'secondaryIdInfos': [{'id': 'ZRHR-PK-01-EU', 'type': 'OTHER', 'domain': 'Philip Morris Products S.A.'}, {'id': '2013-003097-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'THS 2.2 then CC', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single product use of THS 2.2)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of CC).', 'interventionNames': ['Other: THS 2.2', 'Other: CC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CC then THS 2.2', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single product use of CC)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of THS 2.2).', 'interventionNames': ['Other: THS 2.2', 'Other: CC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'THS 2.2 then NNS', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single product use of THS 2.2)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single administration of NNS)', 'interventionNames': ['Other: THS 2.2', 'Other: NNS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NNS then THS 2.2', 'description': 'Each subject will follow the below study design:\n\n* Day 0 = Wash-out (1 day)\n* Day 1 = 1st intervention (single administration of NNS)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of THS 2.2).', 'interventionNames': ['Other: THS 2.2', 'Other: NNS']}], 'interventions': [{'name': 'THS 2.2', 'type': 'OTHER', 'description': 'Single use of the Tobacco Heating System 2.2 (THS 2.2)', 'armGroupLabels': ['CC then THS 2.2', 'NNS then THS 2.2', 'THS 2.2 then CC', 'THS 2.2 then NNS']}, {'name': 'CC', 'type': 'OTHER', 'description': "Single use of subject's own conventional cigarette (CC)", 'armGroupLabels': ['CC then THS 2.2', 'THS 2.2 then CC']}, {'name': 'NNS', 'type': 'OTHER', 'description': 'Single administration of 1 mg of nicotine', 'armGroupLabels': ['NNS then THS 2.2', 'THS 2.2 then NNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 6AD', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Celerion GB Ltd, 22-24 Lisburn Road', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Christelle Haziza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}, {'name': 'Adrian Johnston Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion GB Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}