[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100297737":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":98,"centralContacts":49,"locations":102,"responsibleParty":116,"collaborators":49,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":49,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":49,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":49,"overallStatus":138,"whyStopped":49,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,17,21,28,36],{"label":9,"type":10,"description":11,"interventionNames":12},"Panel 1: Treatment A","EXPERIMENTAL","Participants will receive odalasvir (ODV) placebo (matching 25 milligram \\[mg\\] ODV \\[1\\*25 mg tablet\\]) and simeprevir (SMV) placebo (matching 150 mg SMV \\[2\\*75 mg capsules\\]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram \\[mg\\] AL-335 \\[3\\*400 mg tablets\\]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin \\[1\\*400 mg capsule\\]) as a single dose on Day 1, 15 and 16 along with moxifloxacin 400 mg (1\\*400 mg capsule) single dose on Day 2 orally under fed conditions.",[13,14,15,16],"Drug: ODV Placebo (Matching 25 mg ODV)","Drug: SMV Placebo (Matching 150 mg SMV)","Drug: AL-335 Placebo (matching 1200 mg AL-335)","Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)",{"label":18,"type":10,"description":19,"interventionNames":20},"Panel 1: Treatment B","Participants will receive odalasvir (ODV) placebo (matching 25 milligram \\[mg\\] ODV \\[1\\*25 mg tablet\\]) and simeprevir (SMV) placebo (matching 150 mg SMV \\[2\\*75 mg capsules\\]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram \\[mg\\] AL-335 \\[3\\*400 mg tablets\\]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin \\[1\\*400 mg capsule\\]) as a single dose on Day 1, 2 and 15 along with moxifloxacin 400 mg (1\\*400 mg capsule) single dose on Day 16 orally under fed conditions.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Panel 1: Treatment C","Participants will receive odalasvir (ODV) placebo (matching 25 milligram \\[mg\\] ODV \\[1\\*25 mg tablet\\]) and simeprevir (SMV) placebo (matching 150 mg SMV \\[2\\*75 mg capsules\\]) once daily on Day 1 and moxifloxacin placebo (matching 400 mg moxifloxacin \\[1\\*400 mg capsule\\]) as a single dose on Day 1, 2, 15 and 16 along with ODV 25 mg (1\\*25 mg tablet) and SMV 150 mg (2\\*75 mg capsule) once daily on Day 2 to 16 and AL-335 1200 mg (3\\*400 mg tablet) single dose on Day 15 orally under fed conditions.",[13,14,16,25,26,27],"Drug: ODV 25 mg","Drug: SMV 150 mg","Drug: AL-335 1200 mg",{"label":29,"type":30,"description":31,"interventionNames":32},"Panel 2: Treatment E","PLACEBO_COMPARATOR","Participants will receive ODV placebo (matching 200 mg ODV \\[4\\*50 mg tablets\\]) on Days 1 and 2; ODV placebo (matching 125 mg ODV \\[2\\*50 mg tablets + 1\\*25 mg tablets\\]) on Days 3 to 7; and ODV placebo (matching 100 mg ODV \\[2\\*50 mg tablets\\] on Days 8 to 14, orally once daily under fed conditions.",[33,34,35],"Drug: ODV Placebo (Matching 200 mg ODV)","Drug: ODV Placebo (Matching 125 mg ODV)","Drug: ODV Placebo (Matching 100 mg ODV)",{"label":37,"type":10,"description":38,"interventionNames":39},"Panel 2: Treatment F","Participants will receive ODV 200 mg (4\\*50 mg tablets) on Days 1 and 2; ODV 125 mg (2\\*50 mg tablets + 1\\*25 mg tablets) on Days 3 to 7, and ODV 100 mg (2\\*50 mg tablets) on Days 8 to 14, orally once daily under fed conditions.",[40,41,42],"Drug: ODV 200 mg","Drug: ODV 125 mg","Drug: ODV 100 mg",[44,50,54,58,62,66,70,74,78,82,86,90,94],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","ODV Placebo (Matching 25 mg ODV)","Participants will receive ODV placebo (matching 25 \\[mg\\] ODV \\[1\\*25 mg tablet\\]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.",[9,18,22],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"ODV Placebo (Matching 200 mg ODV)","Participants will receive ODV placebo (matching 200 mg ODV \\[4\\*50 mg tablets\\]) on Days 1 and 2 in Treatment E.",[29],{"type":45,"name":55,"description":56,"armGroupLabels":57,"otherNames":49},"ODV Placebo (Matching 125 mg ODV)","Participants will receive ODV placebo (matching 125 mg ODV \\[2\\*50 mg tablets + 1\\*25 mg tablets\\]) orally once daily on Days 3 to 7 in Treatment E.",[29],{"type":45,"name":59,"description":60,"armGroupLabels":61,"otherNames":49},"ODV Placebo (Matching 100 mg ODV)","Participants will receive ODV placebo (matching 100 mg ODV \\[2\\*50 mg tablets\\] orally once daily on Days 8 to 14 in Treatment E.",[29],{"type":45,"name":63,"description":64,"armGroupLabels":65,"otherNames":49},"SMV Placebo (Matching 150 mg SMV)","Participants will receive SMV Placebo (matching 150 mg SMV \\[2\\*75 mg capsules\\]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.",[9,18,22],{"type":45,"name":67,"description":68,"armGroupLabels":69,"otherNames":49},"AL-335 Placebo (matching 1200 mg AL-335)","Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 \\[3\\*400 mg tablets\\]) administered orally on Day 15 in Treatment A and B.",[9,18],{"type":45,"name":71,"description":72,"armGroupLabels":73,"otherNames":49},"Moxifloxacin Placebo (matching 400 mg moxifloxacin)","Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin \\[1\\*400 mg capsule\\]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.",[9,18,22],{"type":45,"name":75,"description":76,"armGroupLabels":77,"otherNames":49},"ODV 25 mg","Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C.",[22],{"type":45,"name":79,"description":80,"armGroupLabels":81,"otherNames":49},"ODV 200 mg","Participants will receive ODV 200 mg (4\\*50 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F.",[37],{"type":45,"name":83,"description":84,"armGroupLabels":85,"otherNames":49},"ODV 125 mg","Participants will receive ODV 125 mg (2\\*50 mg tablets + 1\\*25 mg tablets) once daily administered on Days 3 to 7 in Treatment F.",[37],{"type":45,"name":87,"description":88,"armGroupLabels":89,"otherNames":49},"ODV 100 mg","Participants will receive ODV 100 mg (2\\*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F.",[37],{"type":45,"name":91,"description":92,"armGroupLabels":93,"otherNames":49},"SMV 150 mg","Participants will receive SMV 150 mg (2\\*75 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C.",[22],{"type":45,"name":95,"description":96,"armGroupLabels":97,"otherNames":49},"AL-335 1200 mg","Participants will receive a single oral dose of AL-335 1200 mg (3\\*400 mg tablets) administered on Day 15 in Treatment C.",[22],[99],{"name":100,"affiliation":5,"role":101},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[103],{"facility":104,"status":49,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":49},"Celerion","Tempe","Arizona","85283","United States","US",{"type":111,"coordinates":112},"Point",[113,114],-111.90931,33.41477,{"lat":114,"lon":113},{"type":117,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100297737","phase-1-a-study-to-evaluate-the-cardiac-safety-of-a-single-dose-of-al-335-administered-on-a-background-of-simeprevir-and-odalasvir-and-of-repeated-doses-of-odalasvir-administered-alone-in-healthy-participants-100297737",false,"NCT03155893","A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants","A Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Subjects","Inclusion Criteria:\n\n* Participants must sign and date an informed consent form (ICF) indicating that he or she understands the purpose of, and the procedures required for, the study and is willing to participate in the study\n* Participant must be healthy on the basis of physical examination, medical history, vital signs, and laboratory tests performed at screening\n* Participant must have a blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic\n* Participant must have a 12-lead electrocardiogram (ECG) (based on the mean value of triplicate ECG parameters) consistent with normal cardiac conduction and function at screening\n* Participant must have an echocardiogram at screening with left ventricular ejection fraction (LVEF) greater than or equal to (\\>=)55 percent (%). Participant should not have any other echocardiogram finding suggestive of clinically relevant cardiomyopathy\n* Female participant must have a negative highly sensitive urine pregnancy test at Day -2 (Panel 1) or Day -4 (Panel 2)\n\nExclusion Criteria:\n\n* Participant has a history of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, constipation, or gastrointestinal surgery that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances\n* Participant with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia, and heart blocks\n* Participant with unusual T-wave morphology (such as bifid T-wave) likely to interfere with corrected QT (QTc) measurements\n* Participant with a past history of sick sinus syndrome, heart arrhythmias (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary; risk factors associated with Torsade de Pointes (TdP) such as hypokalemia; family history of short\u002Flong QT syndrome; sudden unexplained death (including sudden infant death syndrome in a first-degree relative \\[that is, sibling, offspring, or biological parent\\])\n* Participant with any skin condition likely to interfere with electrocardiogram (ECG) electrode placement or adhesion\n* Participant with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues",true,"ALL","18 Years","55 Years",{"count":130,"type":131},59,"ACTUAL","INTERVENTIONAL",[134],"PHASE1","The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo on QT\u002FQT interval corrected for heart rate (QTc) interval changes, using intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT\u002FQTc and PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy participants.",[137],"Healthy","COMPLETED","2017-11-10",{"date":141,"type":131},"2017-11-14",{"date":143,"type":131},"2017-05-12",{"date":145,"type":131},"2017-10-27",{"name":5,"class":6},1]