Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-01-26 @ 11:07 AM
Study NCT ID:
NCT01967706
Status:
COMPLETED
Last Update Posted:
2020-03-18
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 Menthol (THS 2.2 Menthol).
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', '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 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 73 subjects: 62 randomized subjects (44 in Group 1, 18 in Group 2) and 11 subjects exposed to mTHS and NRT from the product trials on Day -1 but not randomized.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'This population comprised the subjects that followed these intervention sequences:\n\n* Sequence "mTHS then mCC"\n* Sequence "mCC then mTHS"', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'This population comprised the subjects that followed these intervention sequences:\n\n* Sequence "mTHS then NRT"\n* Sequence "NRT then mTHS"', 'otherNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Enrolled But Not Randomized', 'description': 'Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'mTHS - 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 "mTHS then mCC"\n* Sequence "mCC then mTHS"'}, {'id': 'OG001', 'title': 'mCC - 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 "mTHS then mCC"\n* Sequence "mCC then mTHS"'}, {'id': 'OG002', 'title': 'mTHS - 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 "mTHS then NRT"\n* Sequence "NRT then mTHS"'}, {'id': 'OG003', 'title': 'NRT - 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 "mTHS then NRT"\n* Sequence "NRT then mTHS"'}], 'classes': [{'categories': [{'measurements': [{'value': '10.70', 'groupId': 'OG000', 'lowerLimit': '8.94', 'upperLimit': '12.80'}, {'value': '12.09', 'groupId': 'OG001', 'lowerLimit': '10.10', 'upperLimit': '14.47'}, {'value': '7.64', 'groupId': 'OG002', 'lowerLimit': '5.39', 'upperLimit': '10.81'}, {'value': '7.52', 'groupId': 'OG003', 'lowerLimit': '5.31', 'upperLimit': '10.64'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '88.47', 'ciLowerLimit': '68.64', 'ciUpperLimit': '114.03', 'estimateComment': 'LS mean ratio (mTHS - Group 1:mCC - Group 1)', 'groupDescription': 'The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0', 'description': 'T0 = start of single product use.\n\nDerived 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 mTHS, mCC and NRT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'mTHS - 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 "mTHS then mCC"\n* Sequence "mCC then mTHS"'}, {'id': 'OG001', 'title': 'mCC - 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 "mTHS then mCC"\n* Sequence "mCC then mTHS"'}, {'id': 'OG002', 'title': 'mTHS - 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 "mTHS then NRT"\n* Sequence "NRT then mTHS"'}, {'id': 'OG003', 'title': 'NRT - 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 "mTHS then NRT"\n* Sequence "NRT then mTHS"'}], 'classes': [{'categories': [{'measurements': [{'value': '23.99', 'groupId': 'OG000', 'lowerLimit': '20.87', 'upperLimit': '27.57'}, {'value': '24.45', 'groupId': 'OG001', 'lowerLimit': '21.27', 'upperLimit': '28.10'}, {'value': '15.61', 'groupId': 'OG002', 'lowerLimit': '11.96', 'upperLimit': '20.37'}, {'value': '27.94', 'groupId': 'OG003', 'lowerLimit': '21.41', 'upperLimit': '36.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.13', 'ciLowerLimit': '80.61', 'ciUpperLimit': '119.46', 'estimateComment': 'LS mean ratio (mTHS - Group 1:mCC - Group 1)', 'groupDescription': 'The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0', 'description': 'T0 = start of single product use.\n\nDerived 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*h/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': 'mTHS Then mCC', '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 mTHS)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of mCC).'}, {'id': 'FG001', 'title': 'mCC Then mTHS', '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 mCC)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of mTHS).'}, {'id': 'FG002', 'title': 'mTHS Then NRT', '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 mTHS)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single administration of NRT)'}, {'id': 'FG003', 'title': 'NRT Then mTHS', '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 NRT)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of mTHS).'}], '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': '22'}, {'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': 'First Intervention (Day 1)', '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': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 1 Day (Day 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'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': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'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 August 2013\n\nAt admission (Day -1), all the subjects performed a product trial (Tobacco Sticks and subsequently NRT gum).\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 = 73 subjects: 11 exposed to mTHS and NRT at Admission but not randomized and 62 randomized as described below:\n\n* Sequence "mTHS then mCC": 22 subjects\n* Sequence "mCC then mTHS": 22 subjects\n* Sequence "mTHS then NRT": 9 subjects\n* Sequence "NRT then mTHS": 9 subjects'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'This population comprises the following sequences:\n\n* Sequence "mTHS then mCC"\n* Sequence "mCC then mTHS"'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'This population comprises the following sequences:\n\n* Sequence "mTHS then NRT"\n* Sequence "NRT then mTHS"'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 23 and 65 years', 'categories': [{'measurements': [{'value': '33.4', 'spread': '10.03', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '7.80', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '9.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'International Organization for Standardization (ISO) nicotine level', 'classes': [{'title': '≤ 0.6 mg', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': '> 0.6 to ≤ 1 mg', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', '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. Subjects with major protocol deviations impacting the evaluation of the results were excluded.\n\n62 randomized subjects : 44 in Group 1, 18 in Group 2.\n\n61 completers: 43 in Group 1 (1 withdrawn subject), 18 in Group 2.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-06-21', 'size': 2188170, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-06T08:17', 'hasProtocol': True}, {'date': '2014-05-08', 'size': 1607230, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-06T08:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2013-10-18', 'resultsFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-29', 'studyFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT', 'timeFrame': 'Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0', 'description': 'T0 = start of single product use.\n\nDerived 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 mTHS, mCC and NRT', 'timeFrame': 'Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0', 'description': 'T0 = start of single product use.\n\nDerived 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', 'Candidate modified risk tobacco product', 'Cigarette', 'Nicotine replacement therapy', 'Nicotine gum'], '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 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is Japanese.\n* Smoking, healthy subject as judged by the Investigator.\n* Subject has smoked at least 10 commercially available mCCs 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 medication (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': 'NCT01967706', 'briefTitle': 'Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).', '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 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.', 'orgStudyIdInfo': {'id': 'ZRHM-PK-05-JP'}, 'secondaryIdInfos': [{'id': 'ZRHM-PK-05-JP', 'type': 'OTHER', 'domain': 'Philip Morris Products S.A.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mTHS then mCC', '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 mTHS)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of mCC).', 'interventionNames': ['Other: mTHS', 'Other: mCC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mCC then mTHS', '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 mCC)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of mTHS).', 'interventionNames': ['Other: mTHS', 'Other: mCC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mTHS then NRT', '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 mTHS)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single administration of NRT)', 'interventionNames': ['Other: mTHS', 'Other: NRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NRT then mTHS', '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 NRT)\n* Day 2 = wash-out\n* Day 3 = 2nd intervention (single product use of mTHS).', 'interventionNames': ['Other: mTHS', 'Other: NRT']}], 'interventions': [{'name': 'mTHS', 'type': 'OTHER', 'description': 'Single use of Tobacco Heating System 2.2 Menthol (mTHS)', 'armGroupLabels': ['NRT then mTHS', 'mCC then mTHS', 'mTHS then NRT', 'mTHS then mCC']}, {'name': 'mCC', 'type': 'OTHER', 'description': "Single use of subject's own menthol cigarette (mCC)", 'armGroupLabels': ['mCC then mTHS', 'mTHS then mCC']}, {'name': 'NRT', 'type': 'OTHER', 'description': 'Single administration of 2 mg gum (Nicorette® 2mg)', 'armGroupLabels': ['NRT then mTHS', 'mTHS then NRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '362 0021', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Ageo Medical Clinic, 3133 Haraichi, Ageo-shi', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}], 'overallOfficials': [{'name': 'Christelle Haziza, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Philip Morris Products S.A.'}, {'name': 'Fumimasa Nobuoka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ageo Medical Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}