[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331517":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":26,"locations":40,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Idorsia Pharmaceuticals Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment sequence AB","EXPERIMENTAL","Period A:\n\nSaline + clazosentan\n\nPeriod B:\n\nRifampicin + clazosentan",[13,14,15],"Drug: Clazosentan","Drug: Rifampicin","Other: Saline (0.9% sodium chloride)",{"label":17,"type":10,"description":18,"interventionNames":19},"Treatment sequence BA","Period B:\n\nRifampicin + clazosentan\n\nPeriod A:\n\nSaline + clazosentan",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Clazosentan","Continuous i.v. infusion of 15 mg\u002Fh of clazosentan for 3 h",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Rifampicin","Single i.v. dose of 600 mg rifampicin for 30 min",[9,17],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"OTHER","Saline (0.9% sodium chloride)","Single i.v infusion of 500 mL saline for 30 min",[9,17],[37],{"name":38,"affiliation":5,"role":39},"Clinical Trials","STUDY_DIRECTOR",[41],{"facility":42,"status":26,"city":43,"state":26,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":26},"QPS Netherlands B.V.","Groningen","9713 GZ","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],6.56667,53.21917,{"lat":51,"lon":50},{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100331517","phase-1-a-study-in-healthy-male-subjects-to-investigate-whether-administration-of-rifampicin-can-affect-the-fate-of-clazosentan-in-the-body-of-clazosentan-100331517",false,"NCT03596294","A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan","A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects","Inclusion Criteria:\n\n* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.\n* Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.\n* Body mass index (BMI) of 18.0 to 30.0 kg\u002Fm2 (inclusive) at Screening.\n* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period.\n* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.\n\nStudy-specific criteria\n\n\\- Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.\n\nExclusion Criteria:\n\n* Previous exposure to clazosentan.\n* Previous exposure to rifampicin within 3 months prior to Screening.\n* Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.\n* Known hypersensitivity or allergy to natural rubber latex.\n* Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening.\n* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.\n* Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening.\n* Positive results from the HIV serology at 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","65 Years",{"count":67,"type":68},14,"ACTUAL","INTERVENTIONAL",[71],"PHASE1","A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan",[74],"Healthy Subjects","COMPLETED","2018-10-22",{"date":78,"type":68},"2018-10-23",{"date":80,"type":68},"2018-07-19",{"date":82,"type":68},"2018-08-03",{"name":5,"class":6},1]