Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02403635
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug-Drug Interaction Study: ASP2151 and Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'C568714', 'term': 'ASP2151'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctinfo@mii.maruho.co.jp', 'phone': '+81-75-325-3255', 'title': 'Maruho Co.,Ltd. Kyoto R&D Center', 'organization': 'Clinical Development Dept.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 32 days after the last dose', 'eventGroups': [{'id': 'EG000', 'title': 'Midazolam', 'description': '7.5 mg midazolam', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ASP2151 After Midazolam', 'description': '400 mg ASP2151 after 7.5 mg midazolam', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Midazolam With ASP2151', 'description': '7.5 mg midazolam with 400 mg ASP2151', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Total', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Energy increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Lip haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Plasma Concentration (Cmax) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '38.8', 'spread': '23.1', 'groupId': 'OG002'}, {'value': '36.8', 'spread': '41.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time of Peak Concentration (Tmax) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.52'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '150'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.28', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '113.1', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '58', 'spread': '29.2', 'groupId': 'OG001'}, {'value': '124.4', 'spread': '31.7', 'groupId': 'OG002'}, {'value': '122.1', 'spread': '37.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Half-life (t1/2) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '37', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '52.7', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '43.7', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '52.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious and Non-Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects'}], 'classes': [{'title': 'Non-serious adverse event', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 32 days after the last dose', 'description': 'Refer to the result of adverse event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Plasma Concentration (Cmax) of 1-hydroxymidazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '33.2', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '40.9', 'groupId': 'OG001'}, {'value': '14.9', 'spread': '35', 'groupId': 'OG002'}, {'value': '14.2', 'spread': '59.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time of Peak Concentration (Tmax) of 1-hydroxymidazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.52'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '150'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.28', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of 1-hydroxymidazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '39', 'spread': '32.3', 'groupId': 'OG001'}, {'value': '42.2', 'spread': '31.3', 'groupId': 'OG002'}, {'value': '40.4', 'spread': '36.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Half-life (t1/2) of 1-hydroxymidazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '47.4', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '35.4', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '42', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trough Plasma Concentration (Ctrough) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 5', 'description': 'Day 5 pre-dose'}, {'id': 'OG001', 'title': 'Day 6', 'description': 'Day 6 pre-dose'}, {'id': 'OG002', 'title': 'Day 7', 'description': 'Day 7 pre-dose'}, {'id': 'OG003', 'title': 'Day 8', 'description': 'Day 8 pre-dose'}, {'id': 'OG004', 'title': 'Day 9', 'description': 'Day 9 pre-dose'}, {'id': 'OG005', 'title': 'Day 10', 'description': 'Day 10 pre-dose'}, {'id': 'OG006', 'title': 'Day 11', 'description': 'Day 11 pre-dose'}, {'id': 'OG007', 'title': 'Day 12', 'description': 'Day 12 pre-dose'}], 'classes': [{'categories': [{'measurements': [{'value': '277.6', 'spread': '73.47', 'groupId': 'OG000'}, {'value': '265.7', 'spread': '64.57', 'groupId': 'OG001'}, {'value': '238.9', 'spread': '65.6', 'groupId': 'OG002'}, {'value': '240.7', 'spread': '67.73', 'groupId': 'OG003'}, {'value': '223.9', 'spread': '63.68', 'groupId': 'OG004'}, {'value': '228.5', 'spread': '67.44', 'groupId': 'OG005'}, {'value': '209.7', 'spread': '66.47', 'groupId': 'OG006'}, {'value': '214.2', 'spread': '50.89', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 5 to 12', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Plasma Concentration (Cmax) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '1761.4', 'spread': '37.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time of Peak Concentration (Tmax) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '17167', 'spread': '31.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '19334.2', 'spread': '31.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Half-life (t1/2) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apparent Volume of Distribution (Vd/F) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '225.9', 'spread': '65.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apparent Total Body Clearance (CL/F) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}], 'classes': [{'categories': [{'measurements': [{'value': '21.61', 'spread': '6.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'spread': '28', 'groupId': 'OG000'}, {'value': '56.7', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '121.9', 'spread': '30.7', 'groupId': 'OG002'}, {'value': '118.9', 'spread': '36.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apparent Volume of Distribution (Vd/F) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '406.5', 'spread': '46.3', 'groupId': 'OG000'}, {'value': '622', 'spread': '47', 'groupId': 'OG001'}, {'value': '370.8', 'spread': '43.1', 'groupId': 'OG002'}, {'value': '366.6', 'spread': '41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apparent Total Body Clearance (CL/F) of Midazolam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Day 1', 'description': '7.5 mg midazolam alone'}, {'id': 'OG001', 'title': 'Day 12', 'description': '7.5 mg midazolam with 400 mg ASP2151'}, {'id': 'OG002', 'title': 'Day 19', 'description': '7.5 mg midazolam alone'}, {'id': 'OG003', 'title': 'Day 26', 'description': '7.5 mg midazolam alone'}], 'classes': [{'categories': [{'measurements': [{'value': '444', 'spread': '187.33', 'groupId': 'OG000'}, {'value': '679.1', 'spread': '276.5', 'groupId': 'OG001'}, {'value': '401.3', 'spread': '163.74', 'groupId': 'OG002'}, {'value': '394', 'spread': '153.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midazolam + ASP2151', 'description': '400 mg ASP2151 followed by 7.5 mg midazolam\n\nMidazolam\n\nASP2151'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Screening (28 Days)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Received the First Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Participants took part in the study at one investigative site in United Kingdom from 18-March 2015 to 28-May 2015'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Midazolam + ASP2151', 'description': '400 mg ASP2151 followed by 7.5 mg midazolam\n\nMidazolam\n\nASP2151'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '7.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2015-03-26', 'resultsFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-09', 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of 1-hydroxymidazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Time of Peak Concentration (Tmax) of 1-hydroxymidazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of 1-hydroxymidazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Half-life (t1/2) of 1-hydroxymidazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Trough Plasma Concentration (Ctrough) of ASP2151', 'timeFrame': 'Days 5 to 12'}, {'measure': 'Peak Plasma Concentration (Cmax) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Time of Peak Concentration (Tmax) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Area Under Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Half-life (t1/2) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Apparent Total Body Clearance (CL/F) of ASP2151', 'timeFrame': 'pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12'}, {'measure': 'Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Apparent Total Body Clearance (CL/F) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}], 'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Time of Peak Concentration (Tmax) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}, {'measure': 'Half-life (t1/2) of Midazolam', 'timeFrame': 'prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious and Non-Serious Adverse Events', 'timeFrame': 'Up to 32 days after the last dose', 'description': 'Refer to the result of adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HSV', 'Herpes', 'volunteers', 'drug-drug interaction'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the induction effect of ASP2151 on that enzyme to determine the extent of any possible drug interactions. The aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP3A4 probe substrate midazolam.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A body mass index (Quetelet index) in the range 18.0-30.9.\n* Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.\n* Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.\n* Willingness to give written consent to have data entered into The Overvolunteering Prevention System.\n\nExclusion Criteria:\n\n* Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.\n* Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).\n* Platelet counts outside normal limits (129,000-346,000/µL).\n* Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.\n* Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.\n* Presence or history of sleep apnoea or myasthenia gravis.\n* History of bleeding diathesis.\n* Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.\n* Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as \\>3), or sensitivity to trial medication.\n* Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4, CYP2C19, CYP2C8 or CYP2C9 metabolic pathways.\n* Use, during the 7 days before the first dose of trial medication, of any over the counter medicine, with the exception of paracetamol (acetaminophen).\n* Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.\n* Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily.\n* Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40\\_100 beats/min. However, if the investigator deems the result to be not clinically significant the subject may be included.\n* Possibility that the volunteer will not cooperate with the requirements of the protocol.\n* Evidence of drug abuse on urine testing.\n* Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.\n* Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.\n* Objection by General Practitioner (GP) to volunteer entering trial."}, 'identificationModule': {'nctId': 'NCT02403635', 'briefTitle': 'Drug-Drug Interaction Study: ASP2151 and Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Europe Limited'}, 'officialTitle': 'A Single-centre, Open-label Study in Healthy Men to Investigate the Effect of Repeated Oral Doses of ASP2151 on the Pharmacokinetics of Midazolam in Healthy Men', 'orgStudyIdInfo': {'id': 'M522101-EU24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Midazolam + ASP2151', 'description': '400 mg ASP2151 followed by 7.5 mg midazolam', 'interventionNames': ['Drug: Midazolam', 'Drug: ASP2151']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Midazolam-ratiopharm'], 'armGroupLabels': ['Midazolam + ASP2151']}, {'name': 'ASP2151', 'type': 'DRUG', 'armGroupLabels': ['Midazolam + ASP2151']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Joachim Dr Kempeni', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maruho Europe Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho Europe Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}