[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Deventer Ziekenhuis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100593074","phase-4-determining-the-effect-of-abiraterone-on-the-metabolism-of-oxycodone-in-men-with-prostate-cancer-the-enable-study-100593074",false,"NCT07001709","Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)","The Effect of Abiraterone on the Metabolism of Oxycodone","ENABLE","Inclusion Criteria:\n\n* Diagnosed prostate cancer;\n* Males aged 18 years or older;\n* Treated with abiraterone 1000 mg once daily for at least 10 days (abiraterone arm).\n* Not treated with abiraterone 1000 mg once daily for at least 10 days (control arm).\n\nExclusion Criteria:\n\n* Use of oxycodone short acting \\\u003C48 hours, or long acting \\\u003C96 hours prior to the study day;\n* Use of other opioids in the 14 days prior to the study day (see also appendix A);\n* Use of other medication that has pharmacokinetic or pharmacodynamics interactions with oxycodone (see also appendix A);\n* Arm 1: dose reduction or successive days of treatment interruption within 10 days prior to the study day (arm 1);\n* Arm 2: treatment with abiraterone within 10 days prior to the study day;\n* A body mass index (BMI) outside the range of 18 - 30 kg\u002Fm2;\n* If hypersensitive to oxycodone;\n* patients suffering from diarrhea\n* If any type of abnormality; active or symptomatic viral hepatitis or chronic liver disease (e.g. classification with Child-Pugh B, Child-Pugh C);\n* Known metastases in the liver that would affect drug metabolism;\n* Patients with a CYP3A4 or CYP2D6 polymorphism;\n* Moderate-severe renal dysfunction (GFR \\\u003C60 ml\u002Fmin\u002F1.73m2) that affects drug metabolism ;\n* Subjects with significant respiratory depression resulting in the need of oxygen therapy or objective hypoventilation (respiratory rate \\\u003C12\u002Fmin);\n* Hypercapnia (venous pCO2 outside the range of 5.5 - 6.7; pH outside the range 7.30 - 7.40);\n* Subjects with, a history of bronchial asthma, chronic obstructive pulmonary disease or pulmonary heart disease;\n* Subjects who started their first cycle of chemotherapy during the 2 weeks before the study day;\n* Major surgery within 1 month prior to screening or planned surgery;\n* A history of drug abuse\n* Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine) and\u002For suffering from opioid withdrawal\n* Patients with evidence of clinically significant gastrointestinal disease;\n* Patients who are contraindicated for blood sampling;\n* Unable to swallow solid, oral dosage forms whole with water;\n* Participation in a clinical trial study at the time of enrolment or within 30 days or 5 half-lives of enrolment, whichever is longer;\n* Previous gastric bypass or gastric band surgery.","MALE","18 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Prostate cancer often leads to bone metastases, which require adequate pain management with opioids such as oxycodone. This study investigates whether abiraterone - a drug used in the treatment of prostate cancer - affects the pharmacokinetics of oxycodone in order to improve pain management.",[27,28],"Prostate Cancer","Pain Cancer","RECRUITING","2025-05-23",{"date":32,"type":33},"2025-06-03","ACTUAL",{"date":35,"type":33},"2024-04-12",{"date":37,"type":21},"2026-01-30",{"name":39,"class":40},"Deventer Ziekenhuis","OTHER",""]