Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-04 @ 11:48 AM
Study NCT ID:
NCT02176005
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of DAV132 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annie.ducher@davolterra.com', 'phone': '+33 1 58 39 32 20', 'title': 'Dr. Annie Ducher, Chief Medical Officer', 'organization': 'Da Volterra'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)', 'eventGroups': [{'id': 'EG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin (400mg x1/day taken orally for 5 days) used alone', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 6, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Moxifloxacin + DAV132', 'description': 'DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 10, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DAV132', 'description': 'DAV132 (7.5g x3/day taken orally for 7 days) used alone', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Negative Control', 'description': 'Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Intestinal transit time abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Formication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}], 'classes': [{'categories': [{'measurements': [{'value': '758.4', 'spread': '359.3', 'groupId': 'OG000'}, {'value': '8.28', 'spread': '7.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.000001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Contrast (B/A)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0093', 'ciLowerLimit': '0.0060', 'ciUpperLimit': '0.0144', 'statisticalMethod': 'General linear model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16', 'unitOfMeasure': 'μg/g.day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}], 'classes': [{'categories': [{'measurements': [{'value': '758.7', 'spread': '359.5', 'groupId': 'OG000'}, {'value': '8.74', 'spread': '7.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.000001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Contrast (B/A)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0096', 'ciLowerLimit': '0.0061', 'ciUpperLimit': '0.0151', 'statisticalMethod': 'General linear model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37', 'unitOfMeasure': 'μg/g.day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}], 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '41.9', 'spread': '9.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Contrast (B/A)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9811', 'ciLowerLimit': '0.8608', 'ciUpperLimit': '1.1182', 'statisticalMethod': 'General linear model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose', 'unitOfMeasure': 'µg/mL.h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '13.83', 'groupId': 'OG000'}, {'value': '50.5', 'spread': '10.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Contrast (B/A)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8785', 'ciLowerLimit': '0.7600', 'ciUpperLimit': '1.0155', 'statisticalMethod': 'General linear model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose', 'unitOfMeasure': 'µg/mL.h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}], 'classes': [{'categories': [{'measurements': [{'value': '4.02', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Contrast (B/A)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1763', 'ciLowerLimit': '0.9982', 'ciUpperLimit': '1.3861', 'statisticalMethod': 'General linear model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.519', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Contrast (B/A)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9391', 'ciLowerLimit': '0.7969', 'ciUpperLimit': '1.1066', 'statisticalMethod': 'General linear model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG002', 'title': 'DAV132', 'description': 'DAV132 oral, 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone'}, {'id': 'OG003', 'title': 'Negative Control', 'description': 'Negative control: 7.5g x3/day for 7 days\n\nNegative Control: Moxifloxacin is used alone'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 37 days after the beginning of treatment', 'unitOfMeasure': 'events related to study product', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Adverse Events Related to Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG001', 'title': 'Moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone\n\nMoxifloxacin: Moxifloxacin is used alone or associated to DAV132'}, {'id': 'OG002', 'title': 'DAV132', 'description': 'DAV132 oral, 7.5g x3/day for 7 days\n\nDAV132: DAV132 is associated to moxifloxacin or it is evaluated alone'}, {'id': 'OG003', 'title': 'Negative Control', 'description': 'Negative control: 7.5g x3/day for 7 days\n\nNegative Control: Moxifloxacin is used alone'}], 'classes': [{'categories': [{'measurements': [{'value': '7.14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 37 days after the beginning of treatment', 'unitOfMeasure': '% of subjects with at last 1 related AE', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin (oral tablets, 400mg x1/day for 5 days) used alone'}, {'id': 'FG001', 'title': 'DAV132 + Moxifloxacin', 'description': 'DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)'}, {'id': 'FG002', 'title': 'DAV132', 'description': 'DAV132 (7.5g x3/day taken orally for 7 days) used alone'}, {'id': 'FG003', 'title': 'Negative Control', 'description': 'Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy volunteers were recruited from March 20th, 2014 (date of first enrolment) and October 17th, 2014 (date of last completed)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Moxifloxacin', 'description': 'Moxifloxacin (400mg x1/day taken orally for 5 days) used alone'}, {'id': 'BG001', 'title': 'DAV132 + Moxifloxacin', 'description': 'DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)'}, {'id': 'BG002', 'title': 'DAV132', 'description': 'DAV132 (7.5g x3/day taken orally for 7 days) used alone'}, {'id': 'BG003', 'title': 'Negative Control', 'description': 'Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '9.1', 'groupId': 'BG002'}, {'value': '36.7', 'spread': '11.8', 'groupId': 'BG003'}, {'value': '35.3', 'spread': '11.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI) at screening visit', 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '24.9', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '23.6', 'spread': '3.2', 'groupId': 'BG002'}, {'value': '23.3', 'spread': '2.0', 'groupId': 'BG003'}, {'value': '24.1', 'spread': '3.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2014-06-25', 'resultsFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-16', 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)', 'timeFrame': 'D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16'}], 'secondaryOutcomes': [{'measure': 'Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)', 'timeFrame': 'D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37'}, {'measure': 'Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1', 'timeFrame': 'D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose'}, {'measure': 'Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5', 'timeFrame': 'D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose'}, {'measure': 'Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1', 'timeFrame': 'D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose'}, {'measure': 'Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5', 'timeFrame': 'D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose'}, {'measure': 'Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product', 'timeFrame': 'From randomization to 37 days after the beginning of treatment'}, {'measure': 'Percentage of Subjects With Adverse Events Related to Study Product', 'timeFrame': 'From randomization to 37 days after the beginning of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '10716083', 'type': 'BACKGROUND', 'citation': 'Edlund C, Beyer G, Hiemer-Bau M, Ziege S, Lode H, Nord CE. Comparative effects of moxifloxacin and clarithromycin on the normal intestinal microflora. Scand J Infect Dis. 2000;32(1):81-5. doi: 10.1080/00365540050164272.'}, {'pmid': '12587622', 'type': 'BACKGROUND', 'citation': 'Burkhardt O, Borner K, Stass H, Beyer G, Allewelt M, Nord CE, Lode H. Single- and multiple-dose pharmacokinetics of oral moxifloxacin and clarithromycin, and concentrations in serum, saliva and faeces. Scand J Infect Dis. 2002;34(12):898-903. doi: 10.1080/0036554021000026963.'}, {'pmid': '29186529', 'type': 'DERIVED', 'citation': 'de Gunzburg J, Ghozlane A, Ducher A, Le Chatelier E, Duval X, Ruppe E, Armand-Lefevre L, Sablier-Gallis F, Burdet C, Alavoine L, Chachaty E, Augustin V, Varastet M, Levenez F, Kennedy S, Pons N, Mentre F, Andremont A. Protection of the Human Gut Microbiome From Antibiotics. J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.', 'detailedDescription': 'The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:\n\n* To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.\n* To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.\n\nIn addition, the security and acceptability of DAV132 used during 7 days will be evaluated.\n\nThe proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Normal digestive transit, with usually one daily stool.\n* Females participating in the study :\n\nmust be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.\n\n* Having given and signed the written study informed consent prior to undertaking any study-related procedure.\n* Covered by the French Health Insurance system.\n\nExclusion Criteria:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.\n* Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.\n* Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.\n* Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.\n* Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.\n* Fecal colonisation by Clostridium difficile.\n* Recent history of hospitalisation (within 3 months prior to inclusion).\n* Any antibiotic administration within 3 months before inclusion.\n* Any vaccination within the last 28 days.'}, 'identificationModule': {'nctId': 'NCT02176005', 'briefTitle': 'Safety and Efficacy Study of DAV132 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Da Volterra'}, 'officialTitle': 'Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DAV132-CL-1002'}, 'secondaryIdInfos': [{'id': 'ID-RCB number 2013-A01504-41', 'type': 'OTHER', 'domain': 'ANSM (French Agency)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'Moxifloxacin, oral tablets, 400mg/day, once daily 5 days', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'moxifloxacin + DAV132', 'description': 'Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days', 'interventionNames': ['Device: DAV132', 'Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'DAV132', 'description': 'DAV132 oral, 7.5g x3/day for 7 days', 'interventionNames': ['Device: DAV132']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Negative control', 'description': 'Negative control: 7.5g x3/day for 7 days', 'interventionNames': ['Other: Negative Control']}], 'interventions': [{'name': 'DAV132', 'type': 'DEVICE', 'description': 'DAV132 is associated to moxifloxacin or it is evaluated alone', 'armGroupLabels': ['DAV132', 'moxifloxacin + DAV132']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'description': 'Moxifloxacin is used alone or associated to DAV132', 'armGroupLabels': ['Moxifloxacin', 'moxifloxacin + DAV132']}, {'name': 'Negative Control', 'type': 'OTHER', 'description': 'Moxifloxacin is used alone', 'armGroupLabels': ['Negative control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75O18', 'city': 'Paris', 'country': 'France', 'facility': 'CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Xavier Duval, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIC Bichat, Paris France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Da Volterra', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}