NL-OMON51266已完成4 期
The Effect of Enzalutamide on Oxycodone Metabolism in Men with Prostate Cancer - ENZYME
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Males aged >= 18 years;
- •- Diagnosed prostate cancer;
- •- Treated with enzalutamide 160 mg once daily for 40 days (arm 1)
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
- •- 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 24 hour prior to oxycodone intake or
- •use of oxycodone extended-release within 2 days prior to oxycodone intake;
- •- use of other medication that would affect oxycodone metabolism, see section
- •5.2 and appendix B of the study protocol;
- •- use of other medication that would affect enzalutamide metabolism, see
- •section 5.2 and appendix B of the study protocol (arm 1).
研究者
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