[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100199479":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":21,"locations":30,"responsibleParty":41,"collaborators":21,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":21,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":21,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":21,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Abiraterone acetate + pioglitazone HCl","EXPERIMENTAL","Participants will receive 15 mg pioglitazone on Day 1 (Period 1). On Day 8 (Period 2), participants will receive 1000 mg abiraterone acetate followed by 15 mg of pioglitazone one hour later.",[13,14],"Drug: Pioglitazone HCl","Drug: Abiraterone acetate",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Pioglitazone HCl","15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Abiraterone acetate","1000 mg tablets administered by mouth on Day 8",[9],[27],{"name":28,"affiliation":5,"role":29},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[31],{"facility":21,"status":21,"city":32,"state":21,"zip":21,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":21},"Merksem","Belgium","BE",{"type":36,"coordinates":37},"Point",[38,39],4.44903,51.24623,{"lat":39,"lon":38},{"type":42,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100199479","phase-1-a-study-to-assess-the-effect-of-abiraterone-jnj-589485-on-the-pharmacokinetics-of-pioglitazone-following-administration-of-abiraterone-acetate-jnj-212082-and-pioglitazone-hcl-tablets-in-healthy-male-participants-100199479",false,"NCT01873001","A Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Participants","An Open-Label Drug-Drug Interaction Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Subjects","Inclusion Criteria:\n\n* Agrees to protocol-defined use of effective contraception for 1 week after receiving the last dose of study drug\n* Agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug\n* Body mass index between 18 and 30 kg\u002Fm2 and body weight not less than 50 kg\n* Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic\n* A 12-lead electrocardiogram consistent with normal cardiac conduction and function\n* Non-smoker\n* Laboratory values within protocol -defined parameters\n\nExclusion Criteria:\n\n* History of or current clinically significant medical illness\n* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator\n* Presence of sexual dysfunction or any medical condition that would affect sexual function\n* Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram\n* Use of any prescription or nonprescription medication (including vitamins and herbal supplements) before the first dose of the study drug is scheduled through study completion\n* History of drug or alcohol abuse within 3 years before screening or positive test result(s) for alcohol and\u002For drugs of abuse at screening and Day -1 and at Day 7 of the treatment period\n* Known allergy to the study drug or any of the excipients of the formulation\n* History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed)\n* Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study\n* Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled\n* Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibodies\n* Preplanned surgery or procedures that would interfere with the conduct of the study",true,"MALE","18 Years","55 Years",{"count":55,"type":56},16,"ACTUAL","INTERVENTIONAL",[59],"PHASE1","The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone acetate in healthy adult male participants.",[62],"Healthy Volunteers",[64,65,66,67,68,23,69,18],"Healthy volunteers","Drug-drug Interaction","Pharmacokinetics","Abiraterone","JNJ-589485","JNJ-212082","COMPLETED","2014-04-16",{"date":73,"type":74},"2014-04-17","ESTIMATED",{"date":76,"type":21},"2013-05",{"date":78,"type":56},"2013-07",{"name":5,"class":6},1]