[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100178108":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":11,"locations":27,"responsibleParty":39,"collaborators":11,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":11,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":11,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[14C]-labeled RO4917523","EXPERIMENTAL",null,[13],"Drug: RO4917523",[15,20],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","RO4917523","\\[14C\\]-labeled RO4917523, single oral dose",[9],{"type":16,"name":17,"description":21,"armGroupLabels":22,"otherNames":11},"\\[13C\\]-labeled RO4917523, single intravenous tracer dose",[9],[24],{"name":25,"affiliation":5,"role":26},"Clinical Trials","STUDY_DIRECTOR",[28],{"facility":11,"status":11,"city":29,"state":11,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":11},"Zuidlaren","9471 GP","Netherlands","NL",{"type":34,"coordinates":35},"Point",[36,37],6.68194,53.09417,{"lat":37,"lon":36},{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100178108","phase-1-a-study-of-the-excretion-balance-pharmacokinetics-and-metabolism-of-a-single-oral-dose-of-14c-labeled-ro4917523-in-healthy-male-volunteers-100178108",false,"NCT01592890","A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers","Single-centre, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Dose of 14C-labeled RO4917523 and an Intravenous Tracer Dose of 13C-labeled RO4917523 in Healthy Male Volunteers","Inclusion Criteria:\n\n* Male adults, 18 to 65 years of age inclusive\n* Body mass index (BMI) 18.0 to 32.0 kg\u002Fm2\n* Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG\n* Medical history without major pathology\n* Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* History of relevant drug and or food allergies\n* Smoking (within 60 days prior to drug administration until the follow-up visit)\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)\n* Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug\n* Infrequent bowel movements (less than once per 2 days)\n* Participation in another ADME study with a radiation burden \\>0,1 mSv in the period of 1 years before the start of the study\n* Positive screen for drugs of abuse\n* Average intake of more than 24 units of alcohol per week\n* Positive for hepatitis B, hepatitis C or HIV infection",true,"MALE","18 Years","65 Years",{"count":53,"type":54},6,"ACTUAL","INTERVENTIONAL",[57],"PHASE1","This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral \\[14C\\]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of \\[14C\\]-labeled RO4917523 and an intravenous tracer dose of \\[13C\\]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.",[60],"Healthy Volunteer","COMPLETED","2016-11-01",{"date":64,"type":65},"2016-11-02","ESTIMATED",{"date":67,"type":11},"2012-04",{"date":69,"type":54},"2012-05",{"name":5,"class":6},1]