Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT01836458
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2013-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552304', 'term': 'NITD 609'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dose 1: 30mg', 'description': 'Single dose of KAE609 30 mg', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose 2: 20mg', 'description': 'Single dose of KAE609 20 mg', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose 3: 10mg', 'description': 'Single dose of KAE609 10 mg', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose 4: 15mg', 'description': 'Single dose of KAE609 15 mg', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Minimum Inhibitory Concentration (MIC) of KAE609', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg'}, {'id': 'OG001', 'title': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg'}, {'id': 'OG002', 'title': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg'}, {'id': 'OG003', 'title': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg'}], 'timeFrame': 'Up to Day 8 after a single dose of KAE609', 'description': 'To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary Outcome Measure (OM) could not be determined due to small sample size no data was collected from any participants.'}, {'type': 'SECONDARY', 'title': 'Median Time to Parasite Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg'}, {'id': 'OG001', 'title': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg'}, {'id': 'OG002', 'title': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg'}, {'id': 'OG003', 'title': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '24.00', 'groupId': 'OG000', 'lowerLimit': '12.00', 'upperLimit': '48.00'}, {'value': '63.00', 'groupId': 'OG001', 'lowerLimit': '36.02', 'upperLimit': '72.00'}, {'value': '54.00', 'comment': 'Only 4 of 7 patients reached time to parasite clearance; therefore, it was not possible to calculate the upper limit of the 95% confidence interval.', 'groupId': 'OG002', 'lowerLimit': '36.05', 'upperLimit': 'NA'}, {'value': '60.00', 'groupId': 'OG003', 'lowerLimit': '36.00', 'upperLimit': '72.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609', 'description': 'Parasite clearance time will be estimated using thick/thin blood films.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Analysis Set includes all enrolled patients'}, {'type': 'SECONDARY', 'title': 'Median Time to Fever Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg'}, {'id': 'OG001', 'title': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg'}, {'id': 'OG002', 'title': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg'}, {'id': 'OG003', 'title': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '9.83', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '11.92'}, {'value': '12.38', 'groupId': 'OG001', 'lowerLimit': '3.83', 'upperLimit': '29.83'}, {'value': '15.75', 'groupId': 'OG002', 'lowerLimit': '0.75', 'upperLimit': '15.83'}, {'value': '11.83', 'groupId': 'OG003', 'lowerLimit': '4.83', 'upperLimit': '35.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 5', 'description': 'Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.', 'unitOfMeasure': 'hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Analysis Set includes all enrolled patients'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg'}, {'id': 'OG001', 'title': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg'}, {'id': 'OG002', 'title': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg'}, {'id': 'OG003', 'title': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg'}], 'classes': [{'title': 'Day 28', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28, Day 35 & Day 42', 'description': 'PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 \\& Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic Analysis Set includes all enrolled patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg'}, {'id': 'FG001', 'title': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg'}, {'id': 'FG002', 'title': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg'}, {'id': 'FG003', 'title': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg'}, {'id': 'BG001', 'title': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg'}, {'id': 'BG002', 'title': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg'}, {'id': 'BG003', 'title': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '11.84', 'groupId': 'BG000'}, {'value': '32.8', 'spread': '7.93', 'groupId': 'BG001'}, {'value': '30.6', 'spread': '8.24', 'groupId': 'BG002'}, {'value': '34.7', 'spread': '8.79', 'groupId': 'BG003'}, {'value': '32.7', 'spread': '9.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'MALE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2013-04-17', 'resultsFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-14', 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum Inhibitory Concentration (MIC) of KAE609', 'timeFrame': 'Up to Day 8 after a single dose of KAE609', 'description': 'To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.'}], 'secondaryOutcomes': [{'measure': 'Median Time to Parasite Clearance', 'timeFrame': 'pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609', 'description': 'Parasite clearance time will be estimated using thick/thin blood films.'}, {'measure': 'Median Time to Fever Clearance', 'timeFrame': 'Day 1 to Day 5', 'description': 'Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.'}, {'measure': 'Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42', 'timeFrame': 'Day 28, Day 35 & Day 42', 'description': 'PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 \\& Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malaria, KAE609'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '27872070', 'type': 'DERIVED', 'citation': 'Hien TT, White NJ, Thuy-Nhien NT, Hoa NT, Thuan PD, Tarning J, Nosten F, Magnusson B, Jain JP, Hamed K. Estimation of the In Vivo MIC of Cipargamin in Uncomplicated Plasmodium falciparum Malaria. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01940-16. doi: 10.1128/AAC.01940-16. Print 2017 Feb.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609', 'detailedDescription': 'There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Monoinfection with P. falciparum confirmed by microscopy\n* Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL\n* Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours\n* Body weight between 40 to 90 kg\n\nKey Exclusion Criteria:\n\n* Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria\n* Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites\n* Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer\n* History of antimalarial use within 2 months of screening\n* Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening\n* Long QT syndrome or QTc using Fridericia's formula \\>430 msec\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases\n* Hemoglobin level \\<10 g/dL\n* Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) \\>2 times the upper limit of normal\n* Renal dysfunction as indicated by serum creatinine \\>2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be \\<2 times the upper limit of normal after oral or parental rehydration\n* Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required\n* Known history of hepatitis B or C; testing is not required\n* Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator\n* Severe vomiting defined as \\>3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours\n* Severe malnutrition defined by a body mass index (BMI) \\<18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting\n* Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening"}, 'identificationModule': {'nctId': 'NCT01836458', 'briefTitle': 'A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label Study to Find the Minimum Inhibitory Concentration(MIC) of KAE609 in Adult Male Patients With Acute, Uncomplicated Malaria Due to Plasmodium Falciparum Monoinfection', 'orgStudyIdInfo': {'id': 'CKAE609A2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1: 30 mg', 'description': 'Single dose of KAE609 30 mg', 'interventionNames': ['Drug: KAE609']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2: 20 mg', 'description': 'Single dose of KAE609 20 mg', 'interventionNames': ['Drug: KAE609']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3: 10 mg', 'description': 'Single dose of KAE609 10 mg', 'interventionNames': ['Drug: KAE609']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4: 15 mg', 'description': 'Single dose of KAE609 15 mg', 'interventionNames': ['Drug: KAE609']}], 'interventions': [{'name': 'KAE609', 'type': 'DRUG', 'description': 'Patients will receive KAE609 single dose at a different dose level in each cohort.', 'armGroupLabels': ['Dose 1: 30 mg', 'Dose 2: 20 mg', 'Dose 3: 10 mg', 'Dose 4: 15 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}