CTIS2023-505705-17-00进行中（未招募）1 期
THE EFFECT OF ABIRATERONE ON THE METABOLISM OF OXYCODONE (ENABLE study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Diagnosed prostate cancer; -Males aged ? 18 years; -Treated with abiraterone 1000 mg once daily for at least 10 days (arm 1). -Not treated with abiraterone 1000 mg once daily for at least 10 days (arm 2).
排除标准
- •-A body mass index (BMI) outside the range of 18 – 30 kg/m2; -If hypersensitive to oxycodone; patients suffering from diarrhoea and/or opioid withdrawal; -If any type of abnormality; active or symptomatic viral hepatitis or chronic liver disease (e.g. classification with Child-Pugh B, Child-Pugh C); -Known metastases in the liver that would affect drug metabolism; -Patients with a CYP3A4 or CYP2D6 polymorphism; -Moderate-severe renal dysfunction (GFR <60 ml/min/1.73m2) that affects drug metabolism ; -Arm 1: dose reduction or successive days of treatment interruption within 10 days prior to the study day (arm 1); -Arm 2: treatment with abiraterone within 10 days prior to the study day; -Subjects with significant respiratory depression, acute or severe bronchial asthma or hypercarbia; -If subjects started first cycle of chemotherapy during the 2 weeks before the screening visit -Major surgery within 1 month prior to screening or planned surgery; -Severe Chronic obstructive pulmonary disease, pulmonary heart disease; -Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine); -Patients with evidence of clinically significant gastrointestinal disease; -Patients who are contraindicated for blood sampling; -Unable to swallow solid, oral dosage forms whole with water; -Participation in a clinical trial study at the time of enrolment or within 30 days or 5 half-lives of enrolment, whichever is longer; -Previous gastric bypass or gastric band surgery.
研究者
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