{"protocolSection":{"identificationModule":{"nctId":"NCT01297062","orgStudyIdInfo":{"id":"BCB112"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects","officialTitle":"A Randomized, Phase 1, Three-Period, Placebo- and Positive-Controlled, Double-Blind, Crossover Study to Assess the Electrophysiological Effects of Exenatide at Therapeutic and Supratherapeutic Concentrations on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects"},"statusModule":{"statusVerifiedDate":"2015-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-02"},"primaryCompletionDateStruct":{"date":"2011-04","type":"ACTUAL"},"completionDateStruct":{"date":"2011-05","type":"ACTUAL"},"studyFirstSubmitDate":"2011-02-09","studyFirstSubmitQcDate":"2011-02-14","studyFirstPostDateStruct":{"date":"2011-02-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-04-27","resultsFirstSubmitQcDate":"2012-04-27","resultsFirstPostDateStruct":{"date":"2012-05-31","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-24","lastUpdatePostDateStruct":{"date":"2015-04-14","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval."},"conditionsModule":{"conditions":["Healthy Subjects"],"keywords":["Diabetes","exenatide","Amylin","Lilly","QT interval"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":94,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","interventionNames":["Drug: Exenatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo comparator"]},{"label":"Moxifloxacin","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Moxifloxacin"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"IV Exenatide (therapeutic and supratherapeutic concentrations)","armGroupLabels":["Exenatide"]},{"type":"DRUG","name":"Moxifloxacin","description":"Oral Moxifloxacin (400 mg)","armGroupLabels":["Moxifloxacin"]},{"type":"DRUG","name":"Placebo comparator","description":"IV Placebo (matching volume of placebo)","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)","description":"Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.","timeFrame":"Baseline, Day 1"},{"measure":"Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)","description":"Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.","timeFrame":"Baseline, Day 2"},{"measure":"Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)","description":"Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.","timeFrame":"Baseline, Day 3"}],"secondaryOutcomes":[{"measure":"Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2","description":"Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.","timeFrame":"Baseline, Day 2"},{"measure":"Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2","description":"Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.","timeFrame":"Baseline, Day 2"},{"measure":"Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2","description":"Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.","timeFrame":"Baseline, Day 2"},{"measure":"Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo","description":"Number of subjects with QTcP \\> 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.","timeFrame":"Day 1, 2, or 3"},{"measure":"Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo","description":"Number of subjects with increase of QTcP interval from baseline \\>30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.","timeFrame":"Baseline, Day 1, 2, or 3"},{"measure":"Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3","description":"The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed.","timeFrame":"Baseline, Day 1, 2, and 3"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Is overtly healthy, as determined by medical history and physical examination\n* Has body mass index (BMI) between 25 and 35 kg/m2\n* Has fasting serum glucose \\<110 mg/dL\n* Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start\n* Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start\n\nExclusion Criteria:\n\n* Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being\n* Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval \\>450 ms.\n* Family history of sudden death\n* Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Vice President Research and Development, MD","affiliation":"Amylin Pharmaceuticals, LLC.","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Research Site","city":"Daytona Beach","state":"Florida","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}},{"facility":"Research Site","city":"Evansville","state":"Indiana","country":"United States","geoPoint":{"lat":37.97476,"lon":-87.55585}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo-Exenatide-Moxifloxacin Sequence","description":"Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;\n\nExenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)\n\nMoxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2\n\nPlacebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"},{"id":"FG001","title":"Exenatide-Moxifloxacin-Placebo Sequence","description":"Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III\n\nExenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)\n\nMoxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2\n\nPlacebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"},{"id":"FG002","title":"Moxifloxacin-Placebo-Exenatide Sequence","description":"Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III\n\nExenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)\n\nMoxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2\n\nPlacebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"},{"id":"FG003","title":"Moxifloxacin-Exenatide-Placebo Sequence","description":"Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III\n\nExenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)\n\nMoxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2\n\nPlacebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"},{"id":"FG004","title":"Placebo-Moxifloxacin-Exenatiden Sequence","description":"Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III\n\nExenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)\n\nMoxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2\n\nPlacebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"},{"id":"FG005","title":"Exenatide-Placebo-Moxifloxacin Sequence","description":"Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III\n\nExenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)\n\nMoxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2\n\nPlacebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"},{"id":"FG006","title":"Non-Randomized","description":"Not Randomized"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"14"},{"groupId":"FG004","numSubjects":"15"},{"groupId":"FG005","numSubjects":"14"},{"groupId":"FG006","numSubjects":"8"}]},{"type":"Intent to Treat (ITT)","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"14"},{"groupId":"FG004","numSubjects":"15"},{"groupId":"FG005","numSubjects":"14"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Evaluable Population","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"13"},{"groupId":"FG004","numSubjects":"13"},{"groupId":"FG005","numSubjects":"13"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"13"},{"groupId":"FG004","numSubjects":"13"},{"groupId":"FG005","numSubjects":"13"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"6"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}]},{"type":"Subject Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo-Exenatide-Moxifloxacin Sequence","description":"Placebo comparator in Period I; 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The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.","populationDescription":"Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"msec","timeFrame":"Baseline, Day 1","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide"},{"id":"OG001","title":"Placebo","description":"Placebo Comparator"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.25","spread":"0.636","lowerLimit":"-3.30","upperLimit":"-1.20"},{"groupId":"OG001","value":"-0.89","spread":"0.599","lowerLimit":"-1.88","upperLimit":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.","pValueComment":"No adjustment on CI for the primary outcome measure.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.36","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.21","ciUpperLimit":"-0.50","estimateComment":"The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept."}]},{"type":"PRIMARY","title":"Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)","description":"Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.","populationDescription":"Evaluable Population. No imputation for missing value was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"msec","timeFrame":"Baseline, Day 2","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide"},{"id":"OG001","title":"Placebo","description":"Placebo Comparator"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.58","spread":"0.640","lowerLimit":"-3.64","upperLimit":"-1.52"},{"groupId":"OG001","value":"-0.56","spread":"0.596","lowerLimit":"-1.54","upperLimit":"0.43"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.","pValueComment":"No adjustment on CI for the primary outcome measure.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-2.02","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.88","ciUpperLimit":"-1.16","estimateComment":"The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept."}]},{"type":"PRIMARY","title":"Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)","description":"Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.","populationDescription":"Evaluable Population. No imputation for missing value was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"msec","timeFrame":"Baseline, Day 3","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide"},{"id":"OG001","title":"Placebo","description":"Placebo Comparator"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.54","spread":"0.675","lowerLimit":"-4.66","upperLimit":"-2.42"},{"groupId":"OG001","value":"-2.41","spread":"0.623","lowerLimit":"-3.44","upperLimit":"-1.38"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.","pValueComment":"No adjustment on CI for the primary outcome measure.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"-1.13","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.11","ciUpperLimit":"-0.15","estimateComment":"The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept."}]},{"type":"SECONDARY","title":"Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2","description":"Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.","populationDescription":"Evaluable Population. 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