EUCTR2020-005087-66-NL进行中（未招募）1 期
The Effect of Enzalutamide on Oxycodone Metabolism in Men with Prostate Cancer - the ENZYME study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Males aged = 18 years;
- •- Diagnosed prostate cancer;
- •- Treated with enzalutamide 160 mg once daily for 40 days (arm 1)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- a body mass index (BMI) outside the range of 18 to 30 kg/m2;
- •- known metastases in the liver that would affect drug metabolism;
- •- Child-Pugh classification B or C that would affect drug metabolism;
- •- known CYP3A4 or CYP2D6 polymorphisms that would affect drug metabolism (patients with a known CYP3A4 or CYP2D6 polymorphism afterwards will be replaced);
- •- known moderate-severe renal dysfunction (GFR <60 ml/min/1.73m2) that would affect drug metabolism;
- •- gastrointestinal disorders that would potentially alter absorption;
- •- previous gastric bypass or gastric band surgery;
- •- known allergy, hypersensitivity or intolerance to normal-release oxycodone;
- •- a history of drug abuse or treatment for abuse;
- •- dose-reduction or =5 successive days of treatment interruption of enzalutamide within 40 days prior to the study day (arm 1);
- •- treatment with enzalutamide within 40 days prior to the study day (arm 2);
- •- use of oxycodone normal-release within 48 hours prior to oxycodone intake or use of oxycodone extended-release within 4 days prior to oxycodone intake;
- •- use of other medication that would affect oxycodone metabolism, see section 5.2 and appendix B;
- •- use of other medication that would affect enzalutamide metabolism, see section 5.2 and appendix B (arm 1).
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