[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100304595":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":35,"locations":40,"responsibleParty":52,"collaborators":35,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":35,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":35,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":35,"overallStatus":74,"whyStopped":35,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Idorsia Pharmaceuticals Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A","EXPERIMENTAL","In the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h",[13],"Drug: Rosuvastatin",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment B1","25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12",[18],"Drug: Aprocitentan",{"label":20,"type":10,"description":21,"interventionNames":22},"Treatment B2","In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h.\n\nDoses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17.",[18,13],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Aprocitentan","Capsule for oral administration",[15,20],[30],"ACT-132577",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Rosuvastatin","Tablet for oral administration",[9,20],null,[37],{"name":38,"affiliation":5,"role":39},"Clinical Trial","STUDY_DIRECTOR",[41],{"facility":42,"status":35,"city":43,"state":35,"zip":44,"country":45,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":51,"contacts":35},"Cepha s.r.o","Pilsen","32300","Czechia",{"type":47,"coordinates":48},"Point",[49,50],13.37759,49.74747,{"lat":50,"lon":49},{"type":53,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100304595","phase-1-a-study-in-healthy-male-subjects-to-investigate-whether-administration-of-act-132577-can-affect-rosuvastatins-fate-in-the-body-amount-and-time-of-presence-in-the-blood-100304595",false,"NCT03245229","A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)","A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects","Inclusion Criteria:\n\n* Signed informed consent in the local language prior to any study mandated procedure;\n* Healthy male subjects aged 18 to 45 years (inclusive) at screening;\n* Body mass index of 18.0 to 28.0 kg\u002Fm2 (inclusive) at screening;\n* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;\n* Hemoglobin ≥ 135 g\u002FL at screening.\n\nExclusion Criteria:\n\n* Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients;\n* Any contraindication for rosuvastatin treatment;\n* History or clinical evidence of myopathy;\n* Asian or Indian-Asian ethnicity;\n* Known hypersensitivity or allergy to natural rubber latex;\n* Previous exposure to ACT-132577;\n* Treatment with rosuvastatin within 3 months prior to screening;\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.",true,"MALE","18 Years","45 Years",{"count":66,"type":67},20,"ACTUAL","INTERVENTIONAL",[70],"PHASE1","The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects",[73],"Healthy Subjects","COMPLETED","2022-11-22",{"date":77,"type":67},"2022-11-29",{"date":79,"type":67},"2017-08-10",{"date":81,"type":67},"2017-09-18",{"name":5,"class":6},1]