Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT02056392
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2014-02-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
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before the first randomised treatment period (Day -1, Visit 2) until the follow-up visit.', 'description': 'Of the 54 participants in the study, 3 did not receive Selumetinib, 3 did not receive Moxifloxacin and 4 did not receive Selumetinib Placebo (due to discontinuing the study).', 'eventGroups': [{'id': 'EG000', 'title': 'Selumetinib', 'description': 'Selumetinib 75mg bs (3x25mg capsules)', 'otherNumAtRisk': 51, 'otherNumAffected': 5, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Moxifloxacin', 'description': 'Moxiflxacin 400 mg (open label)', 'otherNumAtRisk': 51, 'otherNumAffected': 5, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Selumetinib placebo (3 capsules)', 'otherNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}, {'units': 'change from baseline', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxiflxacin 400 mg (open label)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Selumetinib placebo (3 capsules)'}, {'id': 'OG002', 'title': 'Selumetinib', 'description': 'Selumetinib 75mg bs (3x25mg capsules)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.5'}, {'value': '-4.1', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '-2.5'}, {'value': '-4.2', 'groupId': 'OG002', 'lowerLimit': '-5.7', 'upperLimit': '-2.7'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.5', 'groupDescription': '47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.1', 'ciLowerLimit': '4.4', 'ciUpperLimit': '7.7', 'groupDescription': '47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '30 min', 'description': 'Change from baseline in QTcF at 30 minutes (msec)', 'unitOfMeasure': 'msec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'change from baseline', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}, {'units': 'change from baseline', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxiflxacin 400 mg (open label)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Selumetinib placebo (3 capsules)'}, {'id': 'OG002', 'title': 'Selumetinib', 'description': 'Selumetinib 75mg bs (3x25mg capsules)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '9.4'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '0.2'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-3.2', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': 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'47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.9', 'ciLowerLimit': '8.3', 'ciUpperLimit': '11.5', 'groupDescription': '47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.', 'statisticalMethod': 'Mixed Models 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non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.'}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '10.1', 'ciLowerLimit': '8.5', 'ciUpperLimit': '11.8', 'groupDescription': '47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 hours', 'description': 'Change from baseline in QTcF at 2 hours (msec)', 'unitOfMeasure': 'msec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'change from baseline', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}, {'units': 'change from baseline', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxiflxacin 400 mg (open label)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Selumetinib placebo (3 capsules)'}, {'id': 'OG002', 'title': 'Selumetinib', 'description': 'Selumetinib 75mg bs (3x25mg capsules)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '10.3'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '-1.6'}, {'value': '-3.3', 'groupId': 'OG002', 'lowerLimit': '-4.8', 'upperLimit': '-1.8'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.5', 'groupDescription': '47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time 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intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 hours', 'description': 'Change from baseline in QTcF at 3 hours (msec)', 'unitOfMeasure': 'msec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'change from baseline', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in QTcF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}, {'units': 'change from baseline', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin', 'description': 'Moxiflxacin 400 mg (open label)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Selumetinib placebo (3 capsules)'}, {'id': 'OG002', 'title': 'Selumetinib', 'description': 'Selumetinib 75mg bs (3x25mg capsules)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '10.1'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '-0.7'}, {'value': '-3.7', 'groupId': 'OG002', 'lowerLimit': '-5.2', 'upperLimit': '-2.2'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.5', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.2', 'groupDescription': '47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 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'title': 'Selumetinib/Moxifloxacin/Selumetinib Placebo'}, {'id': 'BG001', 'title': 'Moxifloxacin/Selumetinib/Selumetinib Placebo'}, {'id': 'BG002', 'title': 'Moxifloxacin/Selumetinib Placebo/Selumetinib'}, {'id': 'BG003', 'title': 'Selumetinib Placebo/Moxifloxacin/Selumetinib'}, {'id': 'BG004', 'title': 'Selumetinib Placebo/Selumetinib/Moxifloxacin'}, {'id': 'BG005', 'title': 'Selumetinib/Selumetinib Placebo/Moxifloxacin'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '7', 'groupId': 'BG000'}, {'value': '25', 'spread': '5', 'groupId': 'BG001'}, {'value': '25', 'spread': '4', 'groupId': 'BG002'}, {'value': '31', 'spread': '8', 'groupId': 'BG003'}, {'value': '28', 'spread': '8', 'groupId': 'BG004'}, {'value': '30', 'spread': '9', 'groupId': 'BG005'}, {'value': '27', 'spread': '7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2014-02-05', 'resultsFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2014-02-05', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-07', 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in QTcF', 'timeFrame': '30 min', 'description': 'Change from baseline in QTcF at 30 minutes (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '1 hour', 'description': 'Change from baseline in QTcF at 1 hour (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '1 hour 30 min', 'description': 'Change from baseline in QTcF at 1 hour 30 min (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '2 hours', 'description': 'Change from baseline in QTcF at 2 hours (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '3 hours', 'description': 'Change from baseline in QTcF at 3 hours (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '4 hours', 'description': 'Change from baseline in QTcF at 4 hours (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '6 hours', 'description': 'Change from baseline in QTcF at 6 hours (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '8 hours', 'description': 'Change from baseline in QTcF at 8 hours (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '12 hours', 'description': 'Change from baseline in QTcF at 12 hours (msec)'}, {'measure': 'Change From Baseline in QTcF', 'timeFrame': '24 hours', 'description': 'Change 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Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must have not smoked in the last 30 days prior to screening for this study. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.\n\nExclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Subjects where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable. 3. Past history of central serous retinopathy or retinal vein thrombosis,intraocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History or presence of any clinically significant disease or disorder in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT02056392', 'briefTitle': 'To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Aged 18 to 45 Years', 'orgStudyIdInfo': {'id': 'D1532C00071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selumetinib 75mg', 'description': 'Volunteers will receive selumetinib 75mg administered by mouth, as a capsule', 'interventionNames': ['Drug: Selumetinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin 400 mg', 'description': 'Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Selumetinib 75mg placebo', 'description': 'Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.', 'interventionNames': ['Drug: selumetinib placebo']}], 'interventions': [{'name': 'Selumetinib', 'type': 'DRUG', 'otherNames': ['AZD6244'], 'description': 'Volunteers will receive 75 mg selumetinib oral dose (Treatment A)', 'armGroupLabels': ['Selumetinib 75mg']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox®'], 'description': 'Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)', 'armGroupLabels': ['Moxifloxacin 400 mg']}, {'name': 'selumetinib placebo', 'type': 'DRUG', 'otherNames': ['AZD6244 placebo'], 'description': 'Volunteers will receive selumetinib placebo oral dose (Treatment C)', 'armGroupLabels': ['Selumetinib 75mg placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Scott Rasmussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles 6700 W 115th Street, Kansas, US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}