[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354253":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":27,"locations":32,"responsibleParty":46,"collaborators":27,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":27,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":27,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":27,"overallStatus":68,"whyStopped":27,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Cyclerion Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Volunteers","EXPERIMENTAL","Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.",[13,14],"Drug: Olinciguat","Drug: Itraconazole",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Olinciguat","Oral Tablet",[9],[22],"IW-1701",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Itraconazole","Oral Capsule",[9],null,[29],{"name":30,"affiliation":5,"role":31},"Bina Tejura, MD","STUDY_DIRECTOR",[33],{"facility":34,"status":27,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":27},"PPD","Austin","Texas","78744","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-97.74306,30.26715,{"lat":44,"lon":43},{"type":47,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100354253","phase-1-a-trial-to-evaluate-the-effect-of-itraconazole-itz-a-cyp3a4-inhibitor-on-the-pharmacokinetics-of-the-soluble-guanylate-cyclase-stimulator-olinciguat-iw-1701-in-healthy-volunteers-100354253",false,"NCT03892499","A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy Volunteers","An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of Olinciguat (IW-1701)","Inclusion Criteria:\n\n* Subject is an ambulatory adult and between 18 and 55 years old (inclusive) at the screening visit\n* Subject is in good health and has no clinically significant findings on physical examination\n* Body mass index is \\> 18 and \\\u003C 30 kg\u002Fm2 at the screening visit\n* Women of reproductive potential must have a negative pregnancy test at screening at at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and until 90 days after receiving the final study drug dose\n* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and until 90 days after receiving the final study drug dose\n* Other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* Any active or unstable clinically significant medical condition\n* Use of any prescribed or non-prescribed medication (except for hormonal birth control)\n* Other exclusion criteria per protocol",true,"ALL","18 Years","55 Years",{"count":60,"type":61},24,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme \\[CYP\\]3A inhibitor) on the pharmacokinetics (PK) of olinciguat",[67],"Healthy","COMPLETED","2019-07-11",{"date":71,"type":61},"2019-07-15",{"date":73,"type":61},"2019-05-03",{"date":75,"type":61},"2019-07-03",{"name":5,"class":6},1]